FAPI-74 PET Scan for Gastrointestinal Cancer

(18F-FAPI-74 GI Trial)

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of \[18F\]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. 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 will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

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 data supports the effectiveness of the treatment 18F-FAPI-74 PET for gastrointestinal cancer?

Research shows that 18F-FAPI-74 PET scans are better than traditional 18F-FDG PET scans at finding primary tumors, cancer spread, and recurrence in gastric, liver, and pancreatic cancers. This means it can help doctors more accurately diagnose and manage these cancers. ^{1 2 3 4 5}

How is the FAPI-74 PET Scan treatment different from other treatments for gastrointestinal cancer?

The FAPI-74 PET Scan is unique because it uses a special imaging technique to detect cancerous cells in the gastrointestinal tract, which may provide more precise information compared to traditional imaging methods. This approach focuses on identifying cancer by targeting specific proteins in the cancer cells, potentially leading to earlier and more accurate diagnosis. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

References

1. United States 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. [2023]

2. United States 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. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]

4. Germany 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. [2023]

5. Germany 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Gastric adenocarcinoma of fundic gland type after Helicobacter pylori eradication: A case report. [2020]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Gastric adenocarcinoma of the fundic gland type: A case report. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Endoscopic and histologic features associated with gastric cancer in familial adenomatous polyposis. [2019]

10. China pubmed.ncbi.nlm.nih.gov

Advanced duodenal neoplasia and carcinoma in familial adenomatous polyposis: outcomes of surgical management. [2022]