Clinical trial · Interventional
Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients
Study Evaluating 68Ga-FAPI-46 Tumor Microenvironment Interaction in Solid Tumor Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patients enrolled onto study. Administratively withdrawn.
Summary
Brief summary (as posted)
This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Solid Tumor Cancer | — | UNRESOLVED | — |
| Solid Tumor Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68 Ga FAPI-46
- description
- Each participant who meets criteria will receive one dose of 68 Ga FAPI-46 via IV and then receive a whole body PET/CT Scan the same day of infusion. Participants will be asked to have a CT/MRI with contrast approximately one week after the study drug infusion and scan. Researchers will compare PET/CT images using 68Ga-FAPI-46 to compare uptake determined by MRI or CT with contrast as usual Standard of Care.
- interventionNames
- Drug: 68Ga-FAPI-46
Primary outcomes (1)
- measure
- Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake.
- timeFrame
- Day 1 Scan to Day 15 Scan.
- description
- PET/CT uptake of 68Ga-FAPI-46 will be compared to uptake parameters determined by MRI or CT with contrast.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 19 years. * Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy * Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment. * Have acceptable kidney function and clinical lab values. Exclusion Criteria: * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment * Females who are currently pregnant or breastfeeding * Severe renal disease or anuria * Inability to lie flat or remain still for the duration of the scan.
References
Publications (0)
Data not yet available