Imaging Solid Tumors with FAP-2286
This study is looking at a new way to image solid tumors, including metastatic cancer (cancer that has spread). It uses special imaging agents called Gallium-68 labelled FAP-2286 or Copper-64 labelled FAP-2286, which are given intravenously (into a vein) before a PET scan (Positron Emission Tomography, a type of imaging scan). These agents attach to a protein called FAP, which is often found in solid tumors. The study aims to see how safe these agents are, how well they are absorbed by the body, and how effectively they can detect tumors and metastatic disease. You may be able to join if you are 18 or older and have a confirmed solid tumor.
- Study design
- This is a multi-arm study planning to enroll 191 participants. It is an interventional study, meaning participants will receive a specific intervention.
- What's involved
- You will receive a single intravenous injection of either Gallium-68 labelled FAP-2286 or Copper-64 labelled FAP-2286. You will then have a PET scan lasting approximately 30 to 45 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored until the end of the day of the injection. Other measurements, like radiation absorbed doses and tumor uptake, will be tracked for up to 3 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Imaging of Solid Tumors Using FAP-2286
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thomas Hope, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Count of participants with treatment-emergent adverse eventsUntil end of day on the day of the injection (1 day total)
The frequency and severity of treatment emergent adverse events following FAP-2286 injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
- Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)Up to 3 days
Volumes of interest of 68Ga- and 64Cu- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs
- Standardized Uptake Values (SUVs) (Cohort 2 only)Up to 3 days
The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.
- Tumor-to-background (TBR) Ratio (Cohort 2 only)Up to 3 days
TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).
- Proportion of positive lesions on FAP-2286 PET (Cohort 3 only)Up to 3 days
Conventional imaging or CT portion of PET/CT scan will be reviewed in conjunction with the FAP-2286 PET images. Lesions will be characterized as positive on FAP-2286 PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging or CT portion of PET/CT scan will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FAP-2286 PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.