Colorectal CancerPhase 2/3NCT07219238
Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
A Phase 2/3 study testing GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) in people with Colorectal Cancer and Gastric Cancers, run by GE Healthcare at 2 sites in 2 countries.
Trial summary
This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancers, Ovarian Cancers
- What is being tested?
- GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2026to Aug 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is ≥18 years of age
- Participant has provided signed informed consent before any study-specific screening procedures
- Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
- Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.
- Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET/CT Imaging Visit
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Participant is able and willing to comply with all study procedures as described in the protocol
Who cannot join
- Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP)
- Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
- Participant needs any intervention that would delay study participation
- Participant has non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work up
- Participant will not be able to complete the study, based on their anticipated life expectancy
- Participant has active bacterial, viral, or fungal infection requiring systemic antibacterial, anti-viral or antifungal therapy (topical medications are permitted)
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- Participant has renal function impairment as defined by:
- For Phase 2: estimated glomerular filtration rate less than 60 mL/min
- For Phase 3: estimated glomerular filtration rate less than 30 mL/min
- Participant has severe hepatic function impairment as defined by:
- Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) and alanine aminotransferase (serum glutamic-pyruvic transaminase): ≤2.5 × upper limit of normal (ULN; ≤5 × ULN for participants with liver metastases)
- Bilirubin: ≤1.5 × ULN or direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- Participant has autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
- Participant has serious co-morbidities or serious non-malignant disease that in the opinion of the investigator, could compromise participant safety and/or protocol objectives
- Participant either received or is planning to receive any other investigational agent within the 28 days prior to the first imaging visit or during study participation (with the exception of the 3-month follow-up period)
- Participant has known or suspected hypersensitivity to any excipients used in GEH300079 (68Ga)
- Participant has severe claustrophobia, is unable to lie flat or fit into the scanner, or is unable to tolerate the PET/CT scan for any reason
- (Phase 3 only) Participant was previously included in Phase 2 of this study
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
BAMF Health
Grand Rapids, Michigan, 49503
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset
Stockholm, 17176
About this study
Official title: A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study.
The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.
- Being tested
- GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
- Keywords
- Peritoneal Carcinomatosis (PC), Pancreatic Cancers, Colorectal cancer, Gastric cancer, FAPI, Ovarian cancer, 68Ga, PET/CT imaging, Diagnostic imaging, Diagnostic performance
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)Drug
Attenuation correction CT will commence after the administration of GEH300079 (68Ga), and immediately before the PET acquisition. The PET acquisition will encompass the participant's vertex through mid-thighs. Images will be acquired at 60 ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| GEH300079 (68Ga) PET/CT Injection | Experimental | Single IV bolus of GEH300079 (68Ga), target activity 3.6 MBq/kg (150-300 MBq). PET/CT scan at 60 ±5 min post-dose (vertex to mid-thigh, ~20-30 min). Phase 2 subset: additional scans at 15 ±5 min and 3 h ±10 min. Receives: Drug: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC.
The co-primary efficacy endpoint is based on region level sensitivity and specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC in participants with colorectal, gastric or ovarian primary cancer. GEH300079 (68Ga) PET/CT images collected during the Phase 2 part will be reviewed by 5 independent readers. Images collected during the Phase 3 part will be reviewed by 3 readers. The superiority of per region sensitivity (respectively specificity) to a pre-specified threshold of 75% (respectively 70%) will be assessed using one-sided Z-tests. The co-primary endpoints will be considered as met if superiority of both per region sensitivity and per region specificity is achieved by at least 3 of the 5 readers in the Phase 2 part, and by at least 2 of the 3 readers in the Phase 3 part.
Measured: Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Secondary outcomes (21)
Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging and non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging.
Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to SoC imaging will be assessed on participants from the ITI using a McNemar test.
Non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to SoC imaging, will be assessed using a restricted maximum likelihood estimate (RMLE) -based score test, with a non-inferiority margin of 10%.
SoC images will be reviewed by 3 independent readers. The co-key secondary endpoints will be met if the co-primary endpoints are met and both co-key secondary endpoints are demonstrated for the same reader, for at least 2 of the 3 pairs of readers.
Measured: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging in Phase 3
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging will be assessed using a McNemar test, in the Phase 3 part.
Measured: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC will be tabulated.
Measured: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Correlation between radiological and surgical/laparoscopic PCI scores
Correlation between radiological PCI scores (based on GEH300079 (68Ga) PET/CT, CT, MR, [18F]FDG PET/CT) and surgical/laparoscopic PCI score.
Measured: Single time point. Baseline SoC images. GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
The number of Positive peritoneal regions and percentage of participants with a difference in the number of Positive peritoneal regions.
The number of Positive peritoneal regions identified by GEH300079 (68Ga) PET/CT, CT, MR, and [18F]FDG PET/CT, and the percentage of participants with a difference in the number of Positive peritoneal regions identified by GEH300079 (68Ga) PET/CT and baseline SoC imaging.
Measured: single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmax of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
SUVmax of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Measured: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmean of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
SUVmean of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Measured: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVpeak of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
SUVpeak of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Measured: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Tumor to-background ratio (TBR) of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
TBR of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Measured: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Contrast-to-noise ratio (CNR) of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
CNR of GEH300079 (68Ga) PET/CT for the largest lesion identified within each peritoneal region from different primary cancers in comparison with [18F]FDG PET/CT.
Measured: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Correlation between FAP expression and GEH300079 (68Ga) PET/CT uptake in PC from different primary cancer in Phase 2
The correlation between GEH300079 (68Ga) PET/CT uptake in PC from different primary cancers and FAP expression measured by IHC in Phase 2.
Measured: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
Percentage of participants for whom GEH300079 (68Ga) PET/CT could have led to a change in treatment plan
Measured: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Percentage of locoregional to systemic (M0 to M1) upstaging induced by GEH300079 (68Ga) PET/CT
Measured: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
GEH300079 (68Ga) PET/CT image quality at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Visual assessment score of overall image quality at 15 ±5 minutes, 60 ±5 minutes, and 3 hours ±10 minutes post-injection, and across different simulated injected activities
Measured: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Tumor to-background ratio (TBR) of GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities
TBR for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
Measured: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Contrast-to-noise ratio (CNR) of GEH300079 (68Ga) PET/CT TBR at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
CNR for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
Measured: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Number of lesions detected by GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Count of lesions (<2 cm, ≥2 cm) for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
Measured: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Size of lesions detected by GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Size of lesions for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
Measured: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Coefficient of Variation (CV) of GEH300079 (68Ga) PET/CT SUV in Background and Reference Tissues at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Variation coefficient of SUV in local background and reference tissues for each GEH300079 (68Ga) PET/CT time point and each simulated injected activity
Measured: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Intra-reader reproducibility for GEH300079 (68Ga) PET/CT
Cohen's kappa statistics with 95% CI for read vs re-read, for each of the readers.
Measured: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Inter-reader agreement for GEH300079 (68Ga) PET/CT
Cohen's kappa statistics with 95% CI for the assessment of agreement between 2 readers. Fleiss's kappa statistics with 95% CI will be provided for the assessment across the readers.
Measured: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219238
- Sponsor's protocol ID
- GE-282-201
- Other IDs
- IND:151901, 2024-519384-18-00
- Status last verified
- Jun 2026
- First submitted
- 9 Oct 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Open-Label, Non-Randomized Study to Evaluate Diagnostic Performance of GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) for Detection of Peritoneal Carcinomatosis (PC) in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
- ClinicalTrials.gov ID
- NCT07219238
- Acronym / sponsor ID
- GE-282-201
- Keywords
- Peritoneal Carcinomatosis (PC), Pancreatic Cancers, Colorectal cancer, Gastric cancer, FAPI, Ovarian cancer, 68Ga, PET/CT imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study.
The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEH300079 (68Ga) PET/CT Injection | Experimental | Drug: GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)Single IV bolus of GEH300079 (68Ga), target activity 3.6 MBq/kg (150-300 MBq). PET/CT scan at 60 ±5 min post-dose (vertex to mid-thigh, ~20-30 min). Phase 2 subset: additional scans at 15 ±5 min and 3 h ±10 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is ≥18 years of age
- Participant has provided signed informed consent before any study-specific screening procedures
- Participant has histopathologically confirmed primary colorectal, gastric or ovarian cancer or PDAC
- Participant has known or suspected PC from the tumor of origin. Suspicion may be based on imaging or clinical findings.
- Participant is scheduled for peritoneal surgery with curative intent, surgical exploration, or laparoscopy, with either: a. No neoadjuvant treatment received, treatment-naïve (i.e., undergoing upfront surgery or laparoscopy) b. Completed systemic treatment (which may include neoadjuvant chemotherapy) before GEH300079 ( 68Ga) PET/CT Imaging Visit
Key exclusion criteria (18 listed)
- Participant is pregnant or breast-feeding, or sexually active and not using or not willing to use an acceptable form of birth control from screening up to 30 days after receiving the investigational medicinal product (IMP)
- Participant has a known disorder that, in the opinion of the investigator, will impact the study procedures
- Participant needs any intervention that would delay study participation
- Participant has non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work up
- Participant will not be able to complete the study, based on their anticipated life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)Attenuation correction CT will commence after the administration of GEH300079 (68Ga), and immediately before the PET acquisition. The PET acquisition will encompass the participant's vertex through mid-thighs. Images will be acquired at 60 ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. | Drug | GEH300079 (68Ga) PET/CT Injection |
Primary outcome
Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC.
Time frame: Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
The co-primary efficacy endpoint is based on region level sensitivity and specificity of GEH300079 (68Ga) PET/CT imaging for the detection of PC in participants with colorectal, gastric or ovarian primary cancer. GEH300079 (68Ga) PET/CT images collected during the Phase 2 part will be reviewed by 5 independent readers. Images collected during the Phase 3 part will be reviewed by 3 readers. The superiority of per region sensitivity (respectively specificity) to a pre-specified threshold of 75% (respectively 70%) will be assessed using one-sided Z-tests. The co-primary endpoints will be considered as met if superiority of both per region sensitivity and per region specificity is achieved by at least 3 of the 5 readers in the Phase 2 part, and by at least 2 of the 3 readers in the Phase 3 part.
21 secondary outcomes
Superiority of the per region sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging and non-inferiority of the per region specificity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging.
Time frame: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Superiority of the per participant sensitivity of GEH300079 (68Ga) PET/CT to detect PC compared to baseline SoC imaging in Phase 3
Time frame: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Per region PPV, NPV, and accuracy and per participant sensitivity, specificity PPV, NPV, and accuracy of GEH300079 (68Ga) PET/CT and baseline SoC imaging to detect PC
Time frame: Single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Correlation between radiological and surgical/laparoscopic PCI scores
Time frame: Single time point. Baseline SoC images. GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
The number of Positive peritoneal regions and percentage of participants with a difference in the number of Positive peritoneal regions.
Time frame: single time point. Baseline SoC images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmax of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVmean of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
SUVpeak of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Tumor to-background ratio (TBR) of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Contrast-to-noise ratio (CNR) of GEH300079 (68Ga) PET/CT in comparison with [18F]FDG PET/CT.
Time frame: Single time point Baseline [18F]FDG PET/CT images vs GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.
Correlation between FAP expression and GEH300079 (68Ga) PET/CT uptake in PC from different primary cancer in Phase 2
Time frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes. Surgery/laparoscopy within 28 days post injection
Percentage of participants for whom GEH300079 (68Ga) PET/CT could have led to a change in treatment plan
Time frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Percentage of locoregional to systemic (M0 to M1) upstaging induced by GEH300079 (68Ga) PET/CT
Time frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
GEH300079 (68Ga) PET/CT image quality at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Tumor to-background ratio (TBR) of GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities
Time frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Contrast-to-noise ratio (CNR) of GEH300079 (68Ga) PET/CT TBR at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Number of lesions detected by GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Size of lesions detected by GEH300079 (68Ga) PET/CT at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Coefficient of Variation (CV) of GEH300079 (68Ga) PET/CT SUV in Background and Reference Tissues at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection, as well as for different simulated injected activities.
Time frame: GEH300079 (68Ga) PET/CT Images acquired at 15 ±5 minutes, 60 ±5 minutes, and 3 hour ±10 minutes post-injection
Intra-reader reproducibility for GEH300079 (68Ga) PET/CT
Time frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Inter-reader agreement for GEH300079 (68Ga) PET/CT
Time frame: Single time point GEH300079 (68Ga) PET/CT Images acquired at 60 minutes ±5 minutes post injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT) in people with Colorectal Cancer and Gastric Cancers, run by GE Healthcare at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Straszacker (+44 7827 845147, michelle.straszacker@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-region sensitivity and Per-region specificity of GEH300079 (68Ga) PET/CT imaging to detect PC. (time frame: Single time point. Images will be acquired at 60 minutes ±5 minutes post injection, with a scan duration of approximately 20 to 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.