Clinical trial · Interventional
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An 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 an imaging technique called 68Ga-FAPi-46 PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with 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 (cancer associated fibroblasts). 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.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cancer of Unknown Primary Site | Malignant Neoplasm of Unknown Primary | ALIAS | 0.90 |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Adrenal Gland Neoplasm | Malignant Adrenal Gland Neoplasm | ONTOLOGY_EXACT |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Radiation | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68 FAPi-46 | Drug | — | 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 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).
- interventionNames
- Procedure: Computed Tomography
- Drug: Gallium Ga 68 FAPi-46
- Procedure: Positron Emission Tomography
- Radiation: 18F-FDG
Primary outcomes (1)
- measure
- Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues
- timeFrame
- At 20-90 minutes after injection]
- description
- Will be quantified by mean and maximum standardized uptake values (SUVmean and SUVmax).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with the following cancer types: * Brain cancer * Bladder cancer * Urothelial cancer * Testicular cancer * Skin cancer * Thyroid cancer * Hepatocellular carcinoma * Cholangiocarcinoma * Thymus cancer * Pleural cancer * Cervical cancer * Adrenal cancer * Neuroendocrine tumors * Hematologic cancer * Cancer of Unkown Primary * Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis * Patients are ≥ 18 years old at the time of the radiotracer administration. * Patient can provide written informed consent * Patient is able to remain still for duration of imaging procedure (up to one hour) Exclusion Criteria: * Patient is pregnant or nursing * Patients with any new cancer therapy between the baseline PET/CT and the investigational FAPI PET/CT * Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data
References
Publications (0)
Data not yet available