[18F]FAPI-74 PET for Stomach and Esophageal Cancer

(FAPI-GO Trial)

Overseen By Bridget Adams

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: SOFIE

Disqualifiers: Metastases, Hypersensitivity, Previous cancer, 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

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique, [18F]FAPI-74 PET/CT, to determine if it can better detect the spread of stomach and esophageal cancer. The technique aims to identify cancer cells that have spread to other parts of the body, aiding in optimal treatment planning. Suitable participants have confirmed stomach or esophageal cancer and are currently undergoing evaluation for treatment planning. This research aims to enhance how doctors stage and treat these cancers. 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 detection.

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 disease in stomach and esophageal cancer?

Research has shown that [18F]FAPI-74 PET/CT is generally well-tolerated. Studies have used it to detect various types of cancer, and no major safety issues have been reported. This method uses a special scan to identify cancer cells in the body.

Since this trial is in Phase 3, earlier studies found [18F]FAPI-74 safe enough for testing in larger groups. This suggests it is likely as safe as other similar scanning methods. Participants in those studies did not experience significant side effects from the treatment.

Overall, [18F]FAPI-74 PET/CT appears to be a promising option with a good safety record based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

[18F]FAPI-74 PET/CT is unique because it offers a new way to visualize and potentially diagnose stomach and esophageal cancer. Unlike traditional imaging methods, which often rely on detecting structural changes in tissues, this technique uses a novel compound, [18F]FAPI-74, that targets fibroblast activation protein (FAP) expressed in cancer cells, making it more specific. Researchers are excited because this could lead to more accurate staging and monitoring of tumors, improving treatment decisions and outcomes for patients.

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

Studies have shown that [18F]FAPI-74 PET/CT, which participants in this trial will receive, detects cancer spots more effectively than the commonly used [18F]FDG PET. In various cancer types, this method identified more cancer in both the original tumor and metastatic areas. Research indicates that [18F]FAPI-74 PET/CT altered the assessment of cancer progression in many patients with stomach cancer. This suggests it might be a superior tool for determining the extent and spread of cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Sherly Mosessian, Ph.D

Principal Investigator

SOFIE

Are You a Good Fit for This Trial?

Adults over 18 with confirmed gastric, esophageal, or gastroesophageal cancer who are being evaluated for treatment planning can join. They must be relatively active (ECOG ≤2), have had a recent CT scan, and women of childbearing potential must agree to use effective contraception.

Inclusion Criteria

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

I have a confirmed diagnosis of cancer in my stomach, esophagus, or where they meet and am being evaluated for treatment.

I am 18 years old or older.

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 imaging

3 months

SOC procedures and interventions captured during this period

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 is testing the effectiveness of a PET/CT scan using [18F]FAPI-74 in detecting metastatic disease in patients with certain types of cancer. It's an open-label study where participants receive one dose and are monitored for three months to assess sensitivity and specificity compared to standard tests.

How Is the Trial Designed?

Group I: Patients with gastric or esophageal cancer 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/PMC10394310/

Initial Evaluation of [18F]FAPI-74 PET for Various ... 18 F FAPI-74 PET showed significantly higher uptake in primary and metastatic lesions of various histopathologically confirmed cancers than did 18 F FDG PET.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07217704?aggFilters=status%3A

NCT07217704 | Using 18F-FAPI PET to Detect Metastatic ... This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/1/40

Fibroblast Activation Protein–Targeted PET/CT with 18F ... We observed that 18F-FAPI-74 PET/CT resulted in changes in TNM staging in 28% and 18% of patients with gastric and pancreatic cancers, ...

4. nature.com nature.com/articles/s44303-024-00053-z

Clinical applications of fibroblast activation protein ... This article summarizes the current state of clinical FAPI-PET imaging as well as potential uses as a theranostic agent.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1076633225005306

Head-to-head Comparison of [68Ga]Ga-FAPI-04 PET and ... [ 68 Ga]Ga-FAPI-04 PET demonstrated superior sensitivity and specificity in primary gastrointestinal cancers and metastases in comparison with [ 18 F]FDG.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299436/

A Systematic Review and Meta-Analysis - PMC Our aim was to assess the diagnostic performance of this novel molecular imaging technique in GC with a systematic review and meta-analysis.

7. sofie.com sofie.com/2023/10/20/fibroblast-activation-protein-targeted-pet-ct-with-18f-fibroblast-activation-protein-inhibitor-74-for-evaluation-of-gastrointestinal-cancer-comparison-with-18f-fdg-pet-ct/

Fibroblast Activation Protein-Targeted PET/CT with 18F- ... 18F-FAPI-74 PET/CT is superior to 18F-FDG PET/CT in detecting primary tumors, local recurrence, lymph node involvement, and bone and visceral metastases.

8. researchgate.net researchgate.net/publication/393973083_Preclinical_evaluation_of_18FAlF-FAPI-74_for_PET_imaging_to_study_cancer-associated_fibroblast_responses_to_radiotherapy

(PDF) Preclinical evaluation of [18F]AlF-FAPI-74 for PET ... Results Biodistribution studies of [ ¹⁸ F]AlF-FAPI-74 showed radiotracer signal in joint/bone structures and intestines in both mouse strains.

9. 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 ...