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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
18
All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq)
Istituto Nazionale dei Tumori | Fondazione IRCCS
Milan, Milano, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"
Meldola, Italy
Safety (AE)
Safety of administration of 68Ga-OncoFAP, assessed based on Common Toxicity Criteria (CTCAE version 5.0)
Time frame: 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
Time frame: 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
Time frame: Assessed on day 1
Biodistribution profile: SUVmax
Uptake of \[68Ga\]Ga-OncoFAP in terms of SUVmax
Time frame: Assessed on day 1
Biodistribution profile: SUVmean
Uptake of \[68Ga\]Ga-OncoFAP in terms of SUVmean
Time frame: Assessed on day 1
Biodistribution profile: SUVsd
Uptake of \[68Ga\]Ga-OncoFAP in terms of SUVsd
Time frame: Assessed on day 1
PK
Pharmacokinetics of \[68Ga\]Ga-OncoFAP based on measurement of residual radioactivity in the blood over time \[MBq/mL
Time frame: Assessed on day 1
Excretion
Metabolism and excretion of \[68Ga\]Ga-OncoFAP based on radioactivity measurements on urine collected at defined timepoints
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IRCCS San Raffaele
Milan, Italy
Time frame: Assessed on day 1
Immunopathology staining
Correlation of \[68Ga\]Ga-OncoFAP uptake with immunopathology staining if and when surgical or biopsy specimen are available
Time frame: Assessed on day 1
Lesion detection rate
Lesion detection rate compared to standard imaging
Time frame: Assessed on day 1