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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04557 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00237403 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Neuroendocrine Research Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic science ([68Ga] Ga-FAPI-04) | Experimental | Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of Gallium Ga 68-DOTA-FAPI-04 ([68Ga]Ga-FAPI-04) | Day 1 | |
| Pharmacokinetics of [68Ga] Ga-FAPI-04 | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue concentrations of [68Ga] Ga-FAPI-04 retention in tumors | Day 1 | |
| Standardized uptake values (SUV) of [68Ga] Ga-FAPI-04 retention in tumors | Will compare the difference in SUVmax uptake within each subject using a two-side, one-sample t-test. |
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Inclusion Criteria:
Age ≥ 18 years old
Current neuroendocrine tumor diagnosis AND high-grade neuroendocrine tumor presentation determined using the following criteria(s):
Able to lie flat for 60 minutes
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Viglianti | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Gallium Ga 68-DOTA-FAPI-04 | Drug | Given IV |
|
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| Positron Emission Tomography | Procedure | Undergo PET scan |
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| Day 1 |
| Clinical diagnostic performance of [68Ga] Ga-FAPI-04 | When a comparison Ga-DOTATATE scan is available, we will look at the uptake in the tumor in the SOC image related to reference tissue and then compare the FAPI-04 uptake. | Day 1 |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000707753 | 68Ga-FAPI |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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