Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients

Study Evaluating 68Ga-FAPI-46 Tumor Microenvironment Interaction in Solid Tumor Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Solid Tumor Cancer; Malignancy; Solid Tumor Malignancy
• Intervention / Treatment: Drug: 68Ga-FAPI-46

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Nicole Jones; Phone Number: 615-936-2807; Email: nicole.l.jones@vumc.org
• Study Contact Backup: Name: Nicole Jones; Phone Number: 615-784-3087; Email: nicole.l.jones@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
      • Contact: Nicole Jones; Phone Number: 615-936-2807; Email: nicole.l.jones@vumc.org
      • Contact: Eben Rosenthal, MD
      • Contact: Nicole Jones; Phone Number: 615-784-3087; Email: nicole.l.jones@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 68 Ga FAPI-46; 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.

Drug: 68Ga-FAPI-46; Participants will receive an IV injection of 68Ga-FAPI-46. Then, shortly after will undergo a PET/CT imaging using the 68Ga-FAPI-46. Additionally, MRI or contrast CT imaging will be conducted, either on the same day or within 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake.	PET/CT uptake of 68Ga-FAPI-46 will be compared to uptake parameters determined by MRI or CT with contrast.	Day 1 Scan to Day 15 Scan.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the ability of 68Ga-FAPI-46 to predict response to ABT	PET/CT imaging with 68Ga-FAPI-46 agent administration (study drug) will be compared to predictive capability of conventional scoring systems (e.g., PD-L1 CPS) scoring from patient biopsy specimens (gold standard). Treatment response values will be determined by the patient's primary treatment team per standard of care assessment. The analysis is exploratory, intended to generate preliminary data for future studies. The proposed sample size is 50 subjects, with approximately two-thirds undergoing contrast-enhanced CT and one-third undergoing MRI. Based on simulations, the margin of error for a 95% confidence interval is expected to range from 0.13 to 0.26 for n = 37, depending on the true correlation (0.8 to 0.5), and from 0.21 to 0.37 for n = 13.	Day 1 Scan to Day 30 follow up with physician

Collaborators and Investigators

• Sponsor: Eben Rosenthal
• Collaborators: Vanderbilt University Medical Center; Vanderbilt-Ingram Cancer Center
• Investigators: Study Director: Eben Rosenthal, MD, Vanderbilt University/Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): September 1, 2032

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: cancer; Immunotherapy; solid tumor; malignancy; anti-body based therapy; abt; antibody based therapy; anti body based therapy
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; FAPI-46
• Other Study ID Numbers: VICCHN25009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study, and the sample size is not designed to support confirmatory conclusions. The analysis is exploratory, intended to generate preliminary data for future studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No