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2023-04-27
2024-10-21
2024-10-21
18
NCT05784597
Philogen S.p.A.
Philogen S.p.A.
INTERVENTIONAL
A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors
The primary objectives of this trial are to evaluate the safety and dosimetry of [68Ga]Ga-OncoFAP for detection/imaging of solid tumors.
Phase I, multicenter study in patients with a confirmed diagnosis of solid tumor among breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma, requiring clinical staging for nodal staging and/or metastatic disease (based on institutional practice and risk stratification). All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq). [68Ga]Ga-OncoFAP biodistribution, PK, and dosimetry of [68Ga]Ga-OncoFAP will be assessed based on a series of PET/CT scans, blood and urine sampling.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-12-15 | N/A | 2024-11-13 |
2023-03-13 | N/A | 2024-11-15 |
2023-03-27 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cohort A 3 female + 3 male patients with a primary tumor only | DRUG: [68Ga]Ga-OncoFAP administration
|
| EXPERIMENTAL: Cohort B Patients with a primary tumor and/or advanced/metastatic disease with a quantifiable number of lesions | DRUG: [68Ga]Ga-OncoFAP administration
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Safety (AE) | Safety of administration of 68Ga-OncoFAP, assessed based on Common Toxicity Criteria (CTCAE version 5.0) | Throughout study, until a maximum of 8 days after the completion of each patient |
| Cohort A: Dosimetry - Effective dose equivalent (mSv) | Effective dose equivalent (mSv) of normal organs following administration of a single dose of [68Ga]Ga-OncoFAP, for patients in cohort A | Assessed on day 1 |
| Cohort A: Dosimetry - Absorbed doses (mGy) | Absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoFAP, for patients in cohort A | Assessed on day 1 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Biodistribution profile: SUVmax | Uptake of [68Ga]Ga-OncoFAP in terms of SUVmax | Assessed on day 1 |
| Biodistribution profile: SUVmean | Uptake of [68Ga]Ga-OncoFAP in terms of SUVmean | Assessed on day 1 |
| Biodistribution profile: SUVsd | Uptake of [68Ga]Ga-OncoFAP in terms of SUVsd | Assessed on day 1 |
| PK | Pharmacokinetics of [68Ga]Ga-OncoFAP based on measurement of residual radioactivity in the blood over time [MBq/mL | Assessed on day 1 |
| Excretion | Metabolism and excretion of [68Ga]Ga-OncoFAP based on radioactivity measurements on urine collected at defined timepoints | Assessed on day 1 |
| Immunopathology staining | Correlation of [68Ga]Ga-OncoFAP uptake with immunopathology staining if and when surgical or biopsy specimen are available | Assessed on day 1 |
| Lesion detection rate | Lesion detection rate compared to standard imaging | Assessed on day 1 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
