Colorectal CancerPhase 1/2NCT07432633
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
A Phase 1/2 study testing [18F]FPyQCP in people with Colorectal Cancer and Epithelial Ovarian Cancer, run by Blue Earth Diagnostics at 2 sites in United States.
Trial summary
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer
- What is being tested?
- [18F]FPyQCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2026to 31 Jan 2028
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
- Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [18F]FPyQCP administration.
- WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study
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- Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease [5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of [18F]FPyQCP administration.
- Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before [18F]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
- Either:
- Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.
- Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. [18F]FPyQCP PET/CT imaging should be performed as close to scheduled procedure as clinically feasible.
- Suspected recurrence after definitive therapy
Who cannot join
- Participants administered any radioisotope within 5 physical half-lives prior to [18F]FPyQCP administration.
- Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [18F]FPyQCP administration.
- Participants who have recently received any other contrast agent (< 24 hours for intravenous agents and < 5 days for oral agents) before the day of [18F]FPyQCP administration.
- Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
- Known hypersensitivity to [18F]FPyQCP or any of its constituents.
- Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.
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- Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).
- Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
- Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.
- Significant renal or hepatic impairment.
- Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FPyQCP administration.
- Cohort A Specific Exclusion Criteria: 12. No prior history of any other cancer, unless treated with curative-intent and disease-free for at least 5 years before Visit 1 (at least 1 year before Visit 1 for basal cell carcinoma, localized squamous cell carcinoma of the skin and in situ carcinoma of cervix).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Steven Rowe, MD
- Not yet recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
Mikhail Doubrovin, MD
About this study
Official title: A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
- Conditions
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer, Invasive Lobular Breast Carcinoma, Pancreatic Ductal Adenocarcinoma
- Being tested
- [18F]FPyQCP
- Keywords
- Positron emission tomography, Fibroblast activation protein
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Ovarian Epithelial, Stomach Neoplasms, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FPyQCPDrug
positron emission tomography (PET)/computed tomography (CT) imaging
| Study group | Role | What they receive |
|---|---|---|
| [18F]FPyQCP PET/CT | Experimental | Each participant will receive [18F]FPyQCP followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2) Receives: Drug: [18F]FPyQCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess radiation dosimetry of [18F]FPyQCP (Cohort A)
Whole body effective dose of a single dose of [18F]FPyQCP
Measured: Up to 360 minutes post injection
Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)
Sensitivity and specificity of [18F]FPyQCP PET/CT compared to composite standard of truth
Measured: Until completion of follow-up procedures, up to 42 days post injection
Secondary outcomes (2)
Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)
Purpose is to evaluate the safety and tolerability of [18F]FPyQCP
Measured: From screening until safety follow-up (48 hours post injection)
Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).
Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with [18F]FPyQCP PET/CT compared to composite SOT and participant and region level detection rates.
Measured: Until completion of follow-up procedures, up to 42 days post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start19 Feb 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (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.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Earth Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Steven Rowe, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432633
- Sponsor's protocol ID
- BED-FAP-121
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of [18F]FPyQCP for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
- ClinicalTrials.gov ID
- NCT07432633
- Acronym / sponsor ID
- BED-FAP-121
- Conditions
- Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer, Invasive Lobular Breast Carcinoma, Pancreatic Ductal Adenocarcinoma
- Keywords
- Positron emission tomography, Fibroblast activation protein
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Blue Earth DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 25 Feb 2026 (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 is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of [18F]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FPyQCP PET/CT | Experimental | Drug: [18F]FPyQCPEach participant will receive [18F]FPyQCP followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
- Eastern Cooperative Oncology Group performance status ≤ 2.
- Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
- Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [18F]FPyQCP administration.
Key exclusion criteria (12 listed)
- Participants administered any radioisotope within 5 physical half-lives prior to [18F]FPyQCP administration.
- Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [18F]FPyQCP administration.
- Participants who have recently received any other contrast agent (< 24 hours for intravenous agents and < 5 days for oral agents) before the day of [18F]FPyQCP administration.
- Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
- Known hypersensitivity to [18F]FPyQCP or any of its constituents.
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 |
|---|---|---|
| [18F]FPyQCPpositron emission tomography (PET)/computed tomography (CT) imaging | Drug | [18F]FPyQCP PET/CT |
Primary outcome
Assess radiation dosimetry of [18F]FPyQCP (Cohort A)
Time frame: Up to 360 minutes post injection
Whole body effective dose of a single dose of [18F]FPyQCP
Assess the diagnostic performance of [18F]FPyQCP in the peritoneum (Cohort B)
Time frame: Until completion of follow-up procedures, up to 42 days post injection
Sensitivity and specificity of [18F]FPyQCP PET/CT compared to composite standard of truth
2 secondary outcomes
Incidence and severity of adverse events using CTCAE version 5.0 (Both Cohorts)
Time frame: From screening until safety follow-up (48 hours post injection)
Further assess the diagnostic performance of [18F]FPyQCP (Cohort B).
Time frame: Until completion of follow-up procedures, up to 42 days 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 28 Oct 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.
Steven Rowe, MD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [18F]FPyQCP in people with Colorectal Cancer and Epithelial Ovarian Cancer, run by Blue Earth Diagnostics at 2 sites in United States.
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 12 inclusion and 12 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 28 Oct 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jamie MacKay, MD, PhD (+447350456887, jamie.mackay@blueearthdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess radiation dosimetry of [18F]FPyQCP (Cohort A) (time frame: Up to 360 minutes post injection). The study lists 2 primary outcomes in all. 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 28 Oct 2026.