[18F]FAPI-74 PET/CT for Pancreatic Cancer

(FAPI-PRO Trial)

Overseen By Bridget Adams

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: SOFIE

Disqualifiers: Metastases, Hypersensitivity, Prior radiopharmaceutical, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new imaging method, [¹⁸F]FAPI-74 PET/CT, detects cancer spread in individuals with pancreatic ductal adenocarcinoma, a type of pancreatic cancer. The focus is on determining the reliability of this method for identifying metastasis, which aids in treatment planning. Individuals diagnosed with this type of pancreatic cancer and planning treatment may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking advancement in cancer imaging.

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

The trial information does not specify if 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 [18F]FAPI-74 PET/CT is safe for detecting metastatic pancreatic cancer?

Research has shown that [18F]FAPI-74 PET/CT has been tested in several studies for its ability to detect cancer. These studies suggest that the imaging method is generally well-tolerated. For those with pancreatic cancer, as in this trial, the process involves a single dose of a special imaging agent used in PET/CT scans.

In previous studies, patients reported few side effects from this imaging agent, with most reactions being mild and temporary. Since this is a Phase 3 study, earlier phases demonstrated that the imaging method was safe enough to continue testing, indicating that serious side effects are uncommon.

As always, those considering joining a trial should consult their healthcare provider to ensure it’s a suitable option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

[18F]FAPI-74 PET/CT is unique because it uses a novel imaging technique to target fibroblast activation protein (FAP) expressed in pancreatic cancer tissue. Unlike traditional imaging methods such as CT or MRI, which often struggle to differentiate between cancerous and healthy tissue, [18F]FAPI-74 PET/CT offers enhanced precision in identifying cancerous cells. Researchers are excited about this treatment because it could lead to earlier and more accurate detection of pancreatic cancer, potentially improving treatment outcomes and survival rates for patients.

What evidence suggests that [18F]FAPI-74 PET/CT is effective for detecting metastatic pancreatic cancer?

Studies have shown that a new type of scan, called [18F]FAPI-74 PET/CT, holds promise for detecting cancer. It may surpass the commonly used [18F]FDG PET/CT scan in identifying cancer. Research suggests that [18F]FAPI-74 provides clearer images of tumors, aiding doctors in assessing the cancer's spread. This trial will specifically evaluate [18F]FAPI-74 PET/CT for patients with pancreatic ductal adenocarcinoma, where early and accurate detection is crucial. The aim is for this method to enhance cancer detection and monitoring, leading to better treatment decisions. ^{1 3 4 6 7}

Who Is on the Research Team?

Sherly Mosessian, Ph.D

Principal Investigator

Sofie Co.

Are You a Good Fit for This Trial?

Adults over 18 with confirmed pancreatic ductal adenocarcinoma (PDAC), who are undergoing staging for treatment planning, can join. They must have had a recent CT scan or plan to get one soon and agree to use effective contraception if necessary. Consent is required before any study procedures.

Inclusion Criteria

I have signed the consent form for this study.

I am 18 years old or older.

I agree to use effective birth control if I am not postmenopausal or surgically sterile.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET/CT Imaging

Participants undergo [¹⁸F]FAPI-74 PET/CT imaging to detect metastatic disease

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after PET/CT imaging

3 months

Multiple visits (in-person) for SOC procedures

Safety Monitoring

Participants are followed-up for safety for 24 to 72 hours after the dose of [¹⁸F]FAPI-74 PET/CT

24-72 hours

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FAPI-74 PET/CT

Trial Overview The trial tests the effectiveness of a PET/CT scan using [18F]FAPI-74 in detecting metastatic disease in PDAC patients. It's an open-label, non-randomized study assessing the sensitivity and specificity of this imaging technique compared to standard-of-care methods over a maximum of 24 months.

How Is the Trial Designed?

Group I: Patients with pancreatic ductal adenocarcinoma receiving [18F]FAPI-74 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

SOFIE

Lead Sponsor

Trials

2

Recruited

180+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11634952/

Prospective Comparison of [18F]FDG and [18F]AIF-FAPI-74 ... [18F]AIF-FAPI-74 PET/CT showed a significantly higher maximum standardized uptake value than [18F]FDG PET/CT did in evaluating primary ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06782412

Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET ... The aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06149

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ... Researchers believe that [18F]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make ...

4. theranostictrials.org theranostictrials.org/studies/cl74bp9il0260ajjfyifam7vu

Pancreatic (GI) This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts ( ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/early/2023/06/01/jnumed.123.265486

Initial Evaluation of [18F]FAPI-74 PET for Various ... 18 F FAPI-74 PET is a promising novel diagnostic modality for various tumors, especially for precise staging before treatment.

6. trials.braintumor.org trials.braintumor.org/trials/NCT06503146

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET ... INCLUSION CRITERIA: - Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07098598

Pancreatic Cancer Diagnosis With FAPI-PET Imaging The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in ...