A Phase 2 interventional study of 68Ga-FAPI-46 PET Scan in Tumor, Solid, sponsored by University Hospital, Essen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by University Hospital, Essen · Phase 2, Interventional, and Diagnostic
This study is to explore the safety and tolerability as well as diagnostic accuracy of 68Ga-FAPI-46 for different FAP-expressing tumor entities by PET.
This study does not offer any treatment for patients with FAP-expressing carcinomas; therefore, patients will be offered state of the art therapeutic options. Routine surgery will be performed within 8 weeks after 68Ga-FAPI-46 PET.
Primary Endpoint:
Positive predictive value (PPV) on a per-region- and per-patient-basis of 68Ga-FAPI-46 PET for detection of histopathology-FAPpositive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).
Secondary Endpoints:
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 158 is above the median of 50 across 7,432 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University Hospital, Essen is the lead sponsor of 116 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Women of child bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study, unless they are using highly effective methods of contraception during the interventional period. Highly effective contraception methods include:
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
Progestogen-only hormonal contraception associated with inhibition of ovulation:
A single-center prospective interventional single-arm clinical trial. All eligible subjects undergo FAPI-PET Scan
Diagnostic Test: 68Ga-FAPI-46 PET Scan
68Ga-FAPI-46 is a radiotracer that binds with high affinity to Fibroblast Activating Protein (FAP). FAP is physiologically expressed in many tissues during embryonic development, but in adults it is expressed only in the context of wound healing, fibrotic processes, and the stroma of many malignancies. Therefore, the study seeks to validate if 68Ga-FAPI-46 PET could be established as a diagnositc tool to detect solid tumors.
Positive predictive value (PPV) on a per-region- and per-patient-basis (table 3) of 68Ga-FAPI46 PET for detection of histopathology-FAP-positive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%).
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Correlation between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Sensitivity and specificity of FAPI-PET on a per-patient and per-region-basis for detection of histopathology-FAP-positive tumor lesions confirmed by histopathology/biopsy
Time frame: within 8 weeks of FAPI-PET scan, when a tumor sample becomes available for immonostaining for FAP
Detection rate of FAPI-PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level
Time frame: up to time point when patient reaches end-of-study criterion (30day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy)
Sensitivity and specificity of FAPI-PET vs. previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histo/biopsy/FU imaging/clinical FU reference standard
Time frame: up to time point when patient reaches end-of-study criterion (30 day, if surgery is performed within 30 days after FAPI-PET or up to 8 weeks, at time of surgery/biopsy)
Inter-reader reproducibility: determination of FAPI-PET scan interpretation reliability by three independent evaluators
Time frame: through study completion, an average of 1 year
Safety (AEs, SAEs, SUSARs)
Time frame: From signing the ICF until day 30 after FAPI-PET scan
Change in staging/prognostic groups per survey of referring physician who was provided with FAPI-PET scan information.
Time frame: through study completion, an average of 1 year
Plan to share: No
Ran from Dec 2021 to primary completion in Mar 2024, 27 months.
Of 393 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 90. This study's 27 months is below that.
Counting every sponsor, half of 555 studies reached it within 52 months; a quarter within 33 and three quarters within 88.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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