Eben Rosenthal
Eben Rosenthal
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.
Solid Tumor Cancer
Solid Tumor Malignancy
Cancer
Malignancy
68Ga-FAPI-46
EARLY_PHASE1
This is a pilot study to compare PET/CT uptake of 68Ga-FAPI-46 to uptake parameters determined by Standard of Care MRI or CT with contrast. Patients with a solid tumor diagnosis who are scheduled to undergo biologic therapy will be included in the study. Following imaging, patients will begin standard of care antibody based therapy and standard of care follow-up. This study is an open label, single institution, pilot study to determine if 68-Ga-FAPI-46 can predict tumor uptake in patients with solid tumor and if the 68-Ga-FAPI-46 uptake in the tumor positively correlates with response to antibody based therapies. A total of 50 subjects will be enrolled in the study. Imaging will take place prior to initiation of treatment. Patients will then be administered an intravenous injection of 68-Ga-FAPI-46 after which subjects will undergo a PET/CT scan shortly after receiving the drug. Subjects will then undergo treatment as determined by their primary team. The study team will chart review subjects for 36 months ± 6 months with the possibility of extending this follow-up depending on immunotherapy treatment duration to extract treatment response information as documented by their primary treatment team. Total duration of active participation per patient may last approximately 45 days. The study will take around 84 ± 6 months from the time the study opens to accrual. The total duration per patient from time of enrollment to chart review is 36 ± 6 months.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 50 participants |
| Masking : | NONE |
| Primary Purpose : | BASIC_SCIENCE |
| Official Title : | Study Evaluating 68Ga-FAPI-46 Tumor Microenvironment Interaction in Solid Tumor Patients |
| Actual Study Start Date : | 2025-06 |
| Estimated Primary Completion Date : | 2029-04 |
| Estimated Study Completion Date : | 2032-09 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 19 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232