Clinical trial NCT06922825: Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients
Official title: Study Evaluating 68Ga-FAPI-46 Tumor Microenvironment Interaction in Solid Tumor Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Solid Tumor Cancer
Solid Tumor Malignancy
Cancer
Malignancy
Keywords: Immunotherapy
anti-body based therapy
abt
antibody based therapy
anti body based therapy
cancer
malignancy
solid tumor
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: Vanderbilt-Ingram Cancer Center
First posted: 2025-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake.
timeFrame: Day 1 Scan to Day 15 Scan.
Secondary outcomes:
measure: Assess the ability of 68Ga-FAPI-46 to predict response to ABT
timeFrame: Day 1 Scan to Day 30 follow up with physician
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Eben Rosenthal, MD
role: STUDY_DIRECTOR
References: