An Exploratory Study of [68Ga]Ga-Fibroblast Activation Protein Inhibitor 4 ([68Ga]Ga-FAPI-04) in Patients With High-Grade Neuroendocrine Neoplasms
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Study Overview
Brief Summary
This early phase I trial determines where and to what degree the tracer [68Ga] Ga-FAPI-04 accumulates in normal and cancer tissues in patients with high grade neuroendocrine cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research [68Ga] Ga-FAPI-04. Because some cancers take up [68Ga] Ga-FAPI-04, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old
- •Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
- •Previous low uptake of [68Ga] Ga-DOTATATE PET/CT scan OR
- •Krenning Score ≥ 3 OR
- •Ki67 index ≥ 20%
- •Able to lie flat for 60 minutes
- •Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
- •Pregnancy or lactation
- •Patient recently underwent surgery with wound healing
Arms & Interventions
Basic science ([68Ga] Ga-FAPI-04)
Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Intervention: Computed Tomography (Procedure)
Basic science ([68Ga] Ga-FAPI-04)
Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Intervention: Gallium Ga 68-DOTA-FAPI-04 (Drug)
Basic science ([68Ga] Ga-FAPI-04)
Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.
Intervention: Positron Emission Tomography (Procedure)
Outcomes
Primary Outcomes
Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04)
Time Frame: Day 1
Pharmacokinetics of [68Ga] Ga-FAPI-04
Time Frame: Day 1
We will monitor/measure the amount of Ga-FAPI-04 seen within different tissue in patients that have neuroendocrine tumors. We will specifically measure the ratio of uptake in the tumors in comparison to reference tissues such as liver or muscle.
Secondary Outcomes
- Clinical diagnostic performance of [68Ga] Ga-FAPI-04(Day 1)
- Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors(Day 1)
- Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors(Day 1)