An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
NCT ID: NCT07132645
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-09-16
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Computed Tomography
Undergo CT scan
Gallium Ga 68-DOTA-FAPI-04
Given IV
Positron Emission Tomography
Undergo PET scan
Interventions
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Computed Tomography
Undergo CT scan
Gallium Ga 68-DOTA-FAPI-04
Given IV
Positron Emission Tomography
Undergo PET scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patient recently underwent surgery with wound healing
18 Years
ALL
No
Sponsors
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Neuroendocrine Research Foundation
UNKNOWN
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Benjamin Viglianti
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2025-04557
Identifier Type: REGISTRY
Identifier Source: secondary_id
HUM00237403
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2024.069
Identifier Type: -
Identifier Source: org_study_id
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