Tumor, SolidEarly Phase 1NCT06126705
18F-AlF-FAPi-04 PET/CT Imaging in Patients With Solid Tumor
A Early Phase 1 study testing Radiation: 18F-AlF-FAPi-04 and Radiation: 18F-FDG in people with Tumor, Solid, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.
Trial summary
To evaluate the potential usefulness of 18F-AlF-FAPi-04 PET/CT for the diagnosis of primary and metastatic lesions in solid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- Radiation: 18F-AlF-FAPi-04 and Radiation: 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2023to Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Obtain/sign informed consent.
- Age ≥18 years, male or female patients.
- Histologically or cytologically confirmed digestive tumors, head and neck squamous cell carcinoma, or peritoneal metastases.
- Cohort 1: Patients with operable or borderline operable resection, scheduled for primary lesion resection and peripheral lymph node dissection, and suspected presence of peripheral lymph node or distant metastasis; The pathological results of the primary lesion and lymph node dissection were obtained.
- Cohort 2: Patients with confirmed or suspected postoperative recurrence or advanced metastasis by routine imaging had at least one measurable lesion; Patients who can undergo imaging follow-up for 3 to 6 months or can undergo pathological biopsy.
- The ECOG score is 0-2
- Patients with adequate organ function.
Who cannot join
- Previously received FAP-targeted radioligand therapy.
- Patients are participating in any other clinical trials or receiving investigational drugs.
- Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain functional integrity of the nervous system.
- Patients with other malignancies that may interfere with disease assessment, who have a prior history of malignancy but have been adequately treated, who have not been treated for more than 3 years prior to enrollment, and who have no evidence of recurrence are eligible to participate in the study.
- Comorbidities with serious or poorly controlled medical conditions, including but not limited to hard-to-control infections, known active hepatitis B or C, or other conditions that investigators believe may impair study participation or collaboration.
- A physical or psychiatric history that may interfere with the purpose and evaluation of the study, or any condition in which the investigator determines that the patient is incapable of cooperating with imaging and procedures.
- Patients who do not consent to effective contraception or restricted sexual practices.
- There are other conditions that the investigator deems unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Huang xiaohong, MM, +86 158 8266 2030, huangxiaohong2@126.com
About this study
To evaluate the potential usefulness of 18F-AlF-FAPi-04 PET/CT for the diagnosis of primary and metastatic lesions in solid cancer.
Read the detailed description
This is a prospective, single-center, two arms, open label, non-randomized study to evaluate the ability of 18F-AlF-FAPi-04 to detect FAP expressing cells in patients with solid tumor, evaluate its biological distribution characteristics, impact on clinical treatment plans, and evaluate imaging differences between different probes. Taking histopathology and imaging follow-up as gold standard, the sensitivity, specificity, and accuracy of 18F-AlF-FAPi-04 PET/CT will be calculated.
- Conditions
- Tumor, Solid
- Being tested
- Radiation: 18F-AlF-FAPi-04, Radiation: 18F-FDG
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: 18F-AlF-FAPi-04Drug
Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis.
Radiation: 18F-FDGDrug
Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients who are surgically resectable or borderline surgically resectable plan to undergo primary lesion resection and peripheral lymph node dissection, and suspect the presence of peripheral lymph nodes or distant metastasis; Pathological results of postoperative primary lesion and lymph node dissection can be obtained Receives: Drug: Radiation: 18F-AlF-FAPi-04; Drug: Radiation: 18F-FDG |
| Group B | Experimental | For patients diagnosed or suspected of postoperative recurrence or late metastasis through routine imaging examination, there is at least one measurable lesion (with a short diameter of ≥ 1.5cm for lymph node lesions and ≥ 1cm for non lymph node lesions); Patients who can undergo imaging follow-up for 3-6 months or undergo pathological biopsy and puncture. Receives: Drug: Radiation: 18F-AlF-FAPi-04; Drug: Radiation: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A: Sensitivity and Specificity of 18F-AlF-FAPi-04
Performance [sensitivity, specificity, accuracy] of 18F-AlF-FAPi-04 PET imaging to detect FAP-expressing cells, using surgical histopathological results as truth standard
Measured: 6 months after last dose administration
Group B: Sensitivity and Specificity of 18F-AlF-FAPi-04
Performance [sensitivity, specificity, accuracy] of 18F-AlF-FAPi-04 PET imaging to detect FAP-expressing cells, using imaging follow-up or histopathological puncture results as truth standard
Measured: 6 months after last dose administration
Secondary outcomes (1)
Biodistribution of 18F-AlF-FAPi-04
The biodistribution of 18F-AlF-FAPi-04 in normal and cancer tissues of patients with various malignancies will be measured by average and maximum standardized uptake value (SUVmean and SUVmax)
Measured: 120 minutes after tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start18 Jul 2023
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang xiaohong, MM, Principal investigator, Affiliated Hospital of North Sichuan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126705
- Sponsor's protocol ID
- TRX0109001
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-AlF-FAPi-04 PET/CT Imaging in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT06126705
- Acronym / sponsor ID
- TRX0109001
- Conditions
- Tumor, Solid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical CollegeUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 13 Nov 2023 (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.
To evaluate the potential usefulness of 18F-AlF-FAPi-04 PET/CT for the diagnosis of primary and metastatic lesions in solid cancer.
Detailed description
This is a prospective, single-center, two arms, open label, non-randomized study to evaluate the ability of 18F-AlF-FAPi-04 to detect FAP expressing cells in patients with solid tumor, evaluate its biological distribution characteristics, impact on clinical treatment plans, and evaluate imaging differences between different probes. Taking histopathology and imaging follow-up as gold standard, the sensitivity, specificity, and accuracy of 18F-AlF-FAPi-04 PET/CT will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Radiation: 18F-AlF-FAPi-04, Drug: Radiation: 18F-FDGPatients who are surgically resectable or borderline surgically resectable plan to undergo primary lesion resection and peripheral lymph node dissection, and suspect the presence of peripheral lymph nodes or distant metastasis; Pathological results of postoperative primary lesion and lymph node dissection can be obtained |
| Group B | Experimental | Drug: Radiation: 18F-AlF-FAPi-04, Drug: Radiation: 18F-FDGFor patients diagnosed or suspected of postoperative recurrence or late metastasis through routine imaging examination, there is at least one measurable lesion (with a short diameter of ≥ 1.5cm for lymph node lesions and ≥ 1cm for non lymph node lesions); Patients who can undergo imaging follow-up for 3-6 months or undergo pathological biopsy and puncture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Obtain/sign informed consent.
- Age ≥18 years, male or female patients.
- Histologically or cytologically confirmed digestive tumors, head and neck squamous cell carcinoma, or peritoneal metastases.
- Cohort 1: Patients with operable or borderline operable resection, scheduled for primary lesion resection and peripheral lymph node dissection, and suspected presence of peripheral lymph node or distant metastasis; The pathological results of the primary lesion and lymph node dissection were obtained.
- Cohort 2: Patients with confirmed or suspected postoperative recurrence or advanced metastasis by routine imaging had at least one measurable lesion; Patients who can undergo imaging follow-up for 3 to 6 months or can undergo pathological biopsy.
Key exclusion criteria (8 listed)
- Previously received FAP-targeted radioligand therapy.
- Patients are participating in any other clinical trials or receiving investigational drugs.
- Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain functional integrity of the nervous system.
- Patients with other malignancies that may interfere with disease assessment, who have a prior history of malignancy but have been adequately treated, who have not been treated for more than 3 years prior to enrollment, and who have no evidence of recurrence are eligible to participate in the study.
- Comorbidities with serious or poorly controlled medical conditions, including but not limited to hard-to-control infections, known active hepatitis B or C, or other conditions that investigators believe may impair study participation or collaboration.
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 |
|---|---|---|
| Radiation: 18F-AlF-FAPi-04Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis. | Drug | Group A, Group B |
| Radiation: 18F-FDGSubjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis. | Drug | Group A, Group B |
Primary outcome
Group A: Sensitivity and Specificity of 18F-AlF-FAPi-04
Time frame: 6 months after last dose administration
Performance [sensitivity, specificity, accuracy] of 18F-AlF-FAPi-04 PET imaging to detect FAP-expressing cells, using surgical histopathological results as truth standard
Group B: Sensitivity and Specificity of 18F-AlF-FAPi-04
Time frame: 6 months after last dose administration
Performance [sensitivity, specificity, accuracy] of 18F-AlF-FAPi-04 PET imaging to detect FAP-expressing cells, using imaging follow-up or histopathological puncture results as truth standard
1 secondary outcome
Biodistribution of 18F-AlF-FAPi-04
Time frame: 120 minutes after tracer injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Huang xiaohong, MM principal investigator
Affiliated Hospital of North Sichuan Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Radiation: 18F-AlF-FAPi-04 and Radiation: 18F-FDG in people with Tumor, Solid, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang xiaohong, MM (+86 158 8266 2030, huangxiaohong2@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group A: Sensitivity and Specificity of 18F-AlF-FAPi-04 (time frame: 6 months after last dose administration). 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 13 Nov 2023.