Clinical trial · Interventional
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Prostate Gland | — | UNRESOLVED | — |
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68 FAPi-46 | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Basic Science (68Ga-FAPi-46 PET/CT)
- description
- Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
- interventionNames
- Procedure: Computed Tomography
- Other: Gallium Ga 68 FAPi-46
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
- timeFrame
- 60 minutes after tracer injection
- description
- To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values \[SUV\], SUVmean and SUVmax.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment * Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion * Patients can provide written informed consent * Patients are able to remain still for duration of imaging procedure (up to one hour) Exclusion Criteria: * Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT
References
Publications (0)
Data not yet available