An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
NCT07132645 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-23
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.
Conditions
- Neuroendocrine Tumor
Interventions
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- DRUG
-
Gallium Ga 68-DOTA-FAPI-04
Given IV
- PROCEDURE
-
Positron Emission Tomography
Undergo PET scan
Sponsors & Collaborators
-
Neuroendocrine Research Foundation
collaborator UNKNOWN -
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
Benjamin Viglianti · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-16
- Primary Completion
- 2027-09-01
- Completion
- 2027-09-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors
NCT03001349 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
NCT01967537 ·Status: COMPLETED ·Phase: PHASE2
-
PET/CT Imaging of Angiogenesis in Patients With Neuroendocrine Tumors Using 68Ga-NODAGA-E[c(RGDyK)]2
NCT03271281 ·Status: COMPLETED ·Phase: PHASE2
-
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
NCT06455761 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)
NCT02174679 ·Status: NO_LONGER_AVAILABLE
-
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
NCT07118176 ·Status: RECRUITING ·Phase: PHASE1
-
68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
NCT01879657 ·Status: COMPLETED ·Phase: NA
-
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
NCT03136328 ·Status: COMPLETED ·Phase: PHASE3
-
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors
NCT06122610 ·Status: RECRUITING ·Phase: PHASE1
-
Preoperative Abdominal Enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT in Peritoneal Carcinomatosis of Gastric Cancer
NCT04778345 ·Status: UNKNOWN ·Phase: NA
-
Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors
NCT04804371 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105
NCT03278275 ·Status: COMPLETED ·Phase: PHASE2
-
AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
NCT03453489 ·Status: COMPLETED ·Phase: PHASE2
-
Dual-Tracer Theranostic PET
NCT05680675 ·Status: COMPLETED ·Phase: NA
-
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
NCT04457258 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
NCT03288597 ·Status: UNKNOWN
-
68Ga-JH04 PET/CT in Patients With Various Types of Cancer
NCT06455735 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors
NCT02078843 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer
NCT00416455 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
68Ga-NI-FAPI PET/CT: First-in-human Study
NCT06688305 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use
NCT03145857 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
NCT06091748 ·Status: RECRUITING ·Phase: PHASE3
-
18F-MFBG PET Imaging of the Norepinephrine Transporter in Neural Crest and Neuroendocrine Tumors
NCT04258592 ·Status: TERMINATED ·Phase: PHASE1
-
Applying PET/MR in Neuroendocrine Tumors - Imaging Dynamic Processes in Both Modalities
NCT04152928 ·Status: UNKNOWN ·Phase: NA
-
[68Ga]Ga-FAPI PET/CT in Gastric and Gastroesophageal Junctional Cancer
NCT05898854 ·Status: COMPLETED ·Phase: PHASE2