[68Ga] Ga-FAPI-04 Imaging for Neuroendocrine Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Pregnancy, Lactation, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe how a special tracer, [68Ga] Ga-FAPI-04, behaves in patients with high-grade neuroendocrine cancer. The tracer enhances PET/CT scans, allowing doctors to identify cancerous areas more clearly. Patients diagnosed with a high-grade neuroendocrine tumor and who have had low results from a previous PET/CT scan may qualify for this trial. Participants must be able to lie flat for about an hour during the scan. The goal is to improve cancer detection, making treatment more precise. As an Early Phase 1 trial, this research focuses on understanding how the tracer works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that [68Ga] Ga-FAPI-04 is safe for imaging neuroendocrine cancer?

Research shows that [68Ga] Ga-FAPI-04 is a promising substance for PET scans, which are special imaging tests. This substance helps doctors locate potential cancer sites in the body. Studies indicate that [68Ga] Ga-FAPI-04 binds well to certain proteins in cancer cells, enhancing cancer detection during scans.

Regarding safety, this is an early study, so researchers are still assessing its safety for people. However, PET scans typically use very small amounts of radioactivity, so the risk is generally low. Few reports of serious side effects have emerged with similar substances in other studies. As this research is still in the early stages, researchers continue to gather data to ensure it is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Gallium Ga 68-DOTA-FAPI-04 is unique because it uses a novel imaging agent that targets fibroblast activation protein (FAP), which is often overexpressed in neuroendocrine tumors. Most current treatments focus on targeting the tumor cells directly, but this approach offers a new way to visualize the tumor and its microenvironment by binding specifically to FAP. Researchers are excited about this treatment because it could provide clearer, more detailed PET/CT imaging, potentially leading to better diagnosis and personalized treatment strategies for patients with neuroendocrine cancer.

What evidence suggests that this imaging technique is effective for neuroendocrine cancer?

Studies have shown that the tracer [68Ga] Ga-FAPI-04, which participants in this trial will receive, can highlight cancer tissues in PET/CT scans by accumulating in them. This method effectively distinguishes between cancerous and normal tissues. However, early findings suggest that [68Ga] Ga-FAPI-04 might not work well for certain types of neuroendocrine tumors, particularly those well-differentiated and resistant to treatments like [177Lu]Lu-DOTATATE. While promising for some cases, it may not be effective for all neuroendocrine cancers. More research is needed to fully understand its effectiveness in different situations. ^{2 3 6 7 8}

Who Is on the Research Team?

Benjamin Viglianti

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This clinical trial is for patients with high-grade neuroendocrine cancer. It's an early phase I trial, which usually means it's one of the first times the scan is being tested in humans. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis and be in suitable health to undergo imaging procedures.

Inclusion Criteria

I have a high-grade neuroendocrine tumor.

I am 18 years old or older.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

My surgical wound has healed.

Pregnancy or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive [68Ga] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gallium Ga 68-DOTA-FAPI-04

Trial Overview The trial tests a new type of PET/CT scan using a tracer called [68Ga] Ga-FAPI-04 to see how well it shows up in cancer versus normal tissues. The goal is to improve imaging techniques for high-grade neuroendocrine tumors by seeing if this tracer provides clearer images than current methods.

How Is the Trial Designed?

Group I: Basic science ([68Ga] Ga-FAPI-04) Experimental Treatment 3 Interventions

Patients receive \[68Ga\] Ga-FAPI-04 IV, followed 1 hour later by PET/CT scan over approximately 25 minutes.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Neuroendocrine Research Foundation

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39477500/

[18F]FDG and [68Ga]Ga-FAPI-04 Imaging for Outcome ... We aimed to quantitatively investigate the prognostic value of PET-based biomarkers on [ 18 F]FDG and [ 68 Ga]Ga-fibroblast activation ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT07132645

An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging ... 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 ...

3. withpower.com withpower.com/trial/early-phase-1-neuroendocrine-tumors-8-2025-749cf

[68Ga] Ga-FAPI-04 Imaging for Neuroendocrine Cancer Trial Overview The trial tests a new type of PET/CT scan using a tracer called [68Ga] Ga-FAPI-04 to see how well it shows up in cancer versus normal tissues.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37947850/

The inferior performance of [68Ga]Ga-FAPI-04 PET/CT as a ... Our preliminary results demonstrated that [ 68 Ga]Ga-FAPI-04 PET/CT mainly failed in well-differentiated NETs refractory to [ 177 Lu]Lu-DOTATATE therapy.

5. ajronline.org ajronline.org/doi/10.2214/AJR.18.19881

Neuroendocrine Tumor Diagnosis and Management Gallium-68-DOTATOC PET also showed better performance (higher sensitivity and similar specificity) than MRI for detecting primary tumors [3]. Gallium-68– ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251280

GMP Standardized Automated Synthesis and Quality Control ... The present work aims to establish standardize automatic synthesis protocols for [ 68 Ga]Ga-PSMA-11, [ 68 Ga]Ga-FAPI-04, [ 68 Ga]Ga-DOTA-NOC and [ 68 Ga]Ga- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9001579/

New PET Radiotracers for the Imaging of Neuroendocrine ... Among all the FAPI tracers, FAPI-04 showed improved FAP binding and pharmacokinetics [63–65]. A single-centre retrospective analysis [66••] ...

8. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use ... Gallium 68–labeled fibroblast activation protein inhibitor PET is an oncologic imaging strategy based on the molecular targeting of fibroblast ...