FAPI-74 PET Scan for Gastrointestinal Cancer

(18F-FAPI-74 GI Trial)

No longer recruiting at 5 trial locations

Overseen By Sherly Mosessian, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SOFIE

Must not be taking: Investigational agents

Disqualifiers: Pregnancy, Breastfeeding, Infections, Autoimmune, others

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

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 tests a special scan called the [18F]FAPI-74 PET/CT, which helps doctors identify certain cells in individuals with gastrointestinal cancers. The scan will be compared to other lab tests to evaluate its effectiveness. The trial is open to those diagnosed with specific GI cancers, such as liver, stomach, pancreatic, or colorectal cancer, who have not received treatment since their last biopsy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on any investigational drugs, you must not have taken them within the past 28 days.

What prior data suggests that the [18F]FAPI-74 PET scan is safe for detecting gastrointestinal cancers?

Research has shown that the [18F]FAPI-74 PET scan is a promising new method for detecting certain types of cancer, particularly before treatment begins. Early results suggest it effectively identifies tumors and other cancer-related changes in the body.

Regarding safety, some information is available. In studies, patients have undergone [18F]FAPI-74 PET scans without major safety issues reported. Participants seem to tolerate the scan well, and no serious unexpected problems have been noted so far.

Since this is a Phase 2 trial, it has already passed some initial safety tests in humans, providing a reasonable level of confidence in its safety. However, participants should always discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the [18F]FAPI-74 PET scan for gastrointestinal cancer because it offers a new way to visualize tumors using a novel compound, [18F]FAPI-74, which targets fibroblast activation protein (FAP) often abundant in cancer cells. Unlike traditional imaging techniques like CT or MRI, which rely on anatomical changes, this PET/CT scan provides a functional image, potentially allowing for more precise detection and assessment of tumors. This approach could lead to more accurate staging and monitoring of cancer, enhancing personalized treatment planning. Additionally, the quick imaging process, occurring just 60 minutes after injection, offers a more convenient and efficient option for patients and healthcare providers.

What evidence suggests that the [18F]FAPI-74 PET scan is effective for detecting gastrointestinal cancer?

Research has shown that [18F]FAPI-74 PET scans, which participants in this trial will receive, are promising for detecting cancer cells in various tumors, including those in the digestive system. Studies have found that this type of PET scan detects cancer more effectively than traditional methods like 18F FDG PET scans. This improved detection may lead to more accurate cancer staging, which is crucial for planning treatment. Specifically, [18F]FAPI-74 PET/CT has improved the staging of pancreatic cancer, aiding doctors in making better treatment decisions. This scan targets a protein called fibroblast activation protein (FAP), often found in tumor cells, making it easier to identify cancer-affected areas. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults with confirmed gastrointestinal cancers (like pancreatic, liver, colorectal, stomach, or bile duct cancer) who have a tissue sample from a biopsy and haven't had treatment since the biopsy can join. They must not be pregnant or breastfeeding without agreeing to discard breast milk for 24 hours post-injection.

Inclusion Criteria

Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent

I haven't had any treatments between my tissue sample and PET scan.

I have been diagnosed with a type of gastrointestinal cancer.

Exclusion Criteria

Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)

Patients receiving any other investigational agent within the past 28 days

I do not have any infections that need strong medication which could affect my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Staging

Initial staging using institutional standard methods before PET scan

1-2 weeks

PET/CT Imaging

Participants receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes later

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 years

What Are the Treatments Tested in This Trial?

Interventions

• [18F]FAPI-74 PET

Trial Overview [18F]FAPI-74 PET/CT scans are being tested to see if they're effective in detecting FAP expressing cells in patients with various GI cancers. The results will be compared to standard imaging and tissue analysis.

How Is the Trial Designed?

Group I: [18F]FAPI-74 PET/CT Experimental Treatment 1 Intervention

Patients receive \[18F\]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later

Who Is Running the Clinical Trial?

SOFIE

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

A 77-year-old woman was diagnosed with gastric adenocarcinoma of fundic gland type (GA-FG) after undergoing Helicobacter pylori eradication therapy, highlighting a potential link between H. pylori treatment and the development of this novel cancer type.

The tumor was successfully removed through endoscopic submucosal dissection, showing no signs of lymphatic or venous invasion, indicating a safe and effective treatment approach for this type of gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric adenocarcinoma of fundic gland type after Helicobacter pylori eradication: A case report. Yu, YN., Yin, XY., Sun, Q., et al.[2020]

A 60-year-old man was diagnosed with gastric adenocarcinoma of the fundic gland type (GA-FG) after an endoscopic examination revealed a depressed lesion in his stomach, leading to a successful endoscopic submucosal dissection (ESD).

One year after the ESD, the patient showed no signs of recurrence and had no symptoms, indicating that the surgical intervention was effective and safe for this rare type of gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric adenocarcinoma of the fundic gland type: A case report. Fan, X., Yang, XS., Bai, P., et al.[2022]

A patient with familial adenomatous polyposis (FAP) developed gastric adenocarcinoma and pyloric gland adenomas, highlighting the increased risk of gastric cancer in FAP patients, particularly in Western and Asian populations.

Genetic analysis revealed specific mutations in the APC and KRAS genes, suggesting that these mutations play a role in the progression from gastric polyps to cancer, similar to the adenoma-carcinoma sequence observed in colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic alteration of colorectal adenoma-carcinoma sequence among gastric adenocarcinoma and dysplastic lesions in a patient with attenuated familial adenomatous polyposis. Tanabe, H., Moriichi, K., Takahashi, K., et al.[2021]

In a study of 61 patients with initial gastric cancer, [68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT showed significantly higher uptake and detection rates for primary tumors compared to [18F]FDG PET/CT, particularly for signet-ring cell carcinoma, with a detection rate of 95.1% versus 73.8%.

[68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT also demonstrated superior sensitivity in detecting peritoneal metastases (92.3% vs 53.8%) and identified more positive lymph nodes than [18F]FDG PET/CT, although both methods underestimated N staging compared to pathological assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superiority of [68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT to [18F]FDG PET/CT in delineating the primary tumor and peritoneal metastasis in initial gastric cancer. Fu, L., Huang, S., Wu, H., et al.[2023]

In a study of 38 patients with gastric cancer, [68Ga]Ga-FAPI-04 PET demonstrated a 100% sensitivity for detecting primary gastric cancer, significantly outperforming [18F]-FDG PET, which had an 82% sensitivity.

[68Ga]Ga-FAPI-04 PET also showed higher standardized uptake values (SUVmax) in larger and more advanced tumors, indicating its potential for better diagnosis and staging of gastric cancer compared to [18F]-FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [68 Ga]Ga-FAPI-04 and [18F]-FDG for the detection of primary and metastatic lesions in patients with gastric cancer: a bicentric retrospective study. Jiang, D., Chen, X., You, Z., et al.[2022]

In a study of 145 patients with familial adenomatous polyposis (FAP), 5.5% developed advanced duodenal neoplasia or cancer, highlighting the need for careful monitoring as patients age, particularly after the fifth decade of life.

Surgical intervention, primarily duodenopancreatectomy, showed a major operative morbidity and mortality rate of 12.5%, indicating that while the surgery is complex, it can be performed safely by experienced surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced duodenal neoplasia and carcinoma in familial adenomatous polyposis: outcomes of surgical management. Campos, FG., Martinez, CAR., Bustamante Lopez, LA., et al.[2022]

In a study involving 120 patients with gastrointestinal cancers, 68Ga-FAPI PET demonstrated a diagnostic accuracy of 95.0%, significantly outperforming conventional imaging and 18F-FDG PET, which had accuracies of 65.1% and 69.0%, respectively.

68Ga-FAPI PET not only provided more accurate staging but also revised treatment plans for 22.9% of patients compared to conventional imaging, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Qin, C., Song, Y., Gai, Y., et al.[2022]

In a study of 10 FAP patients with gastric cancer (GC) and 40 matched controls, specific endoscopic features such as carpeting of gastric polyps and solitary polyps larger than 20 mm were strongly associated with the presence of GC, highlighting the need for careful surveillance in FAP patients.

Patients with GC also exhibited a higher prevalence of gastric adenomas and polyps with high-grade dysplasia, indicating that advanced pathology is present in FAP-related GC and emphasizing the importance of monitoring for early cancer precursors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic and histologic features associated with gastric cancer in familial adenomatous polyposis. Leone, PJ., Mankaney, G., Sarvapelli, S., et al.[2019]

In a study of 41 participants with gastric, duodenal, and colorectal cancers, 68 Ga-FAPI-04 PET/CT demonstrated superior sensitivity compared to 18 F-FDG PET/CT for detecting tumor recurrence, nodal metastases, and distant metastases.

Specifically, 68 Ga-FAPI-04 PET/CT achieved 100% sensitivity for tumor recurrence and nodal metastases, and 93% for distant metastases, indicating its potential to enhance accuracy in cancer re-evaluation and improve treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 18 F-FDG and 68 Ga-FAPI-04 Uptake in Postoperative Re-evaluation of Gastric, Duodenal, and Colorectal Cancers. Liu, H., Yang, X., Liu, L., et al.[2023]

In a study of 112 patients with gastric, liver, and pancreatic cancers, 18F-FAPI-74 PET/CT demonstrated significantly higher sensitivity than 18F-FDG PET/CT for detecting primary tumors, local recurrences, and metastases, indicating its potential as a more effective imaging tool for these cancers.

The use of 18F-FAPI-74 PET/CT led to upstaging of cancer in 25% of treatment-naïve patients and altered clinical management in 9% of patients with suspected recurrence or metastases, highlighting its impact on patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast Activation Protein-Targeted PET/CT with 18F-Fibroblast Activation Protein Inhibitor-74 for Evaluation of Gastrointestinal Cancer: Comparison with 18F-FDG PET/CT. Xu, W., Cai, J., Peng, T., et al.[2023]

Citations

1. 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.

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05641896

NCT05641896 | Study of [18F]FAPI-74 PET in Patients With ... The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results ...

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

Clinical applications of fibroblast activation protein ... Nine representative oncologic patients who underwent 18F-FDG and 18F-FAPI-74 PET imaging. 18F-FAPI-74 PET outperforms 18F-FDG PET in ...

5. link.springer.com link.springer.com/article/10.1007/s11307-024-01950-w

Prospective Comparison of [ 18 F]FDG and [ 18 F]AIF-FAPI ... This study demonstrated that [ 18 F]AIF-FAPI-74 PET/CT could improve the clinical staging of potentially resectable PDAC.

6. 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37884330/

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

8. sofie.com sofie.com/2025/10/01/sofie-biosciences-prepares-launch-of-two-18ffapi-74-phase-3-studies-following-successful-fda-engagement/

SOFIE Biosciences Prepares Launch of Two [18F]FAPI-74 ... Secondary objectives were to evaluate the safety profile and accuracy of [18F]FAPI-74 PET in detecting the presence of GI malignancies. The ...