Imaging of Solid Tumors Using FAP-2286
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Hope
About this trial
This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years.
Ability to understand a written informed consent document, and the willingness to sign it.
Disqualifiers
Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
Known pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Gallium-68 labelled (68Ga-) FAP-2286
DrugThe dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Positron Emission Tomography (PET) imaging
Procedure/SurgeryParticipants will be scanned for approximately 30 to 45 minutes
Copper-64 labeled (64Cu-) FAP-2286
DrugThe dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Treatment groups
191 Participants
are divided into 4 treatment groupsGroup A: CLOSED - 68Ga-Dosimetry population (Cohort 1a)Experimental treatment 2 interventions
Group B: CLOSED - 64Cu-Dosimetry population (Cohort 1b)Experimental treatment 2 interventions
Group C: Participants with metastatic disease (Cohort 2)Experimental treatment 3 interventions
Group D: Participants without metastatic disease (Cohort 3)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Count of participants with treatment-emergent adverse events
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
Time frame
Until end of day on the day of the injection (1 day total)2
Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)
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
Time frame
Up to 3 days3
Standardized Uptake Values (SUVs) (Cohort 2 only)
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.
Time frame
Up to 3 days4
Tumor-to-background (TBR) Ratio (Cohort 2 only)
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).
Time frame
Up to 3 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Thomas Hope
Lead sponsor
University of California, San Francisco
Sponsor institution
Society of Abdominal Radiology
Collaborator
Source ClinicalTrials.gov