68Ga-FAPI-46 PET/CT Scan for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Hypersensitivity, Emergency surgery, Metastatic, 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: 4

130 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment 68Ga-FAPI-46 PET/CT Scan for Pancreatic Cancer?

Research shows that 68Ga-FAPI PET/CT scans can improve tumor detection and staging in pancreatic cancer compared to traditional methods, potentially identifying cancers at an earlier stage. ^{1 2 3 4 5}

Is the 68Ga-FAPI-46 PET/CT scan safe for humans?

The 68Ga-FAPI PET/CT scan has been used in various studies for imaging tumors and other conditions, and while it shows promise in diagnosing cancers, the safety data specifically for humans is not detailed in the available research. However, it is widely used in clinical settings, suggesting a general acceptance of its safety. ^{3 6 7 8 9}

How does the 68Ga-FAPI-46 PET/CT scan treatment differ from other treatments for pancreatic cancer?

The 68Ga-FAPI-46 PET/CT scan is unique because it uses a special tracer that targets fibroblast activation protein, which can improve the detection and staging of pancreatic cancer compared to the more commonly used 18F-FDG PET/CT scans. This can lead to better identification of both primary tumors and metastatic lesions, potentially improving treatment planning. ^{1 2 3 4 10}

What is the purpose of this trial?

This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells in large amounts. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.

Research Team

Ajit H. Goenka, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults over 18 with localized pancreatic ductal adenocarcinoma (PDA) who haven't started treatment yet. They should be fit enough for surgery after initial therapy and have an ECOG performance status of 0-2, meaning they can care for themselves. Pregnant women, those allergic to ingredients in the scan compound, or patients needing emergency surgery cannot participate.

Inclusion Criteria

My cancer is localized and planned for surgery after initial treatment.

I can take care of myself and am up and about more than half of the day.

Ability to provide informed consent

Exclusion Criteria

Pregnant or lactating women

I need emergency surgery.

My cancer is confirmed to be metastatic pancreatic ductal adenocarcinoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive 68Ga-FAP-46 intravenously and undergo a PET/CT scan at baseline before standard of care therapy

1 day

1 visit (in-person)

Re-staging Imaging

Participants undergo up to 2 PET/CT scans approximately 8 weeks apart at standard of care re-staging visits

16 weeks

2 visits (in-person)

Pre-surgical Imaging

Participants undergo a PET/CT scan within 4 weeks of standard of care surgical resection, if applicable

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Computed Tomography
• Gallium Ga 68 FAPi-46
• Positron Emission Tomography

Trial Overview The trial is testing a new type of PET/CT scan using a radioactive compound called 68Ga-FAPI-46 that targets cancer-associated fibroblasts in PDA. The goal is to see if this method improves diagnosis and management by providing clearer images of where the cancer cells are located.

Participant Groups

Group I: Diagnostic (gallium GA 68 FAPi-46, PET/CT) Experimental Treatment 3 Interventions

Patients receive 68Ga-FAP-46 IV, then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before SOC therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 51 pancreatic cancer patients, [68Ga]Ga-DOTA-FAPI-04 PET/CT demonstrated superior sensitivity compared to [18F]FDG PET/CT for detecting primary tumors (100% vs. 95%), metastatic lymph nodes (96.2% vs. 61.5%), and distant metastases (100% vs. 84%), indicating it may be a more effective diagnostic tool.

The study found that a SUVmax greater than 14.9 on [68Ga]Ga-DOTA-FAPI-04 PET/CT was significantly associated with better progression-free survival rates, suggesting it could serve as an independent prognostic factor for patients with pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The added value of [68Ga]Ga-DOTA-FAPI-04 PET/CT in pancreatic cancer: a comparison to [18F]F-FDG. Liu, Q., Shi, S., Liu, S., et al.[2023]

In a study of 36 patients with suspected pancreatic malignancies, [68Ga]Ga-FAPI PET/CT demonstrated significantly higher sensitivity and radiotracer uptake compared to [18F]FDG PET/CT for detecting primary tumors, lymph node involvement, and metastases.

[68Ga]Ga-FAPI PET/CT also improved TNM staging in 26.1% of cases compared to [18F]FDG, indicating its potential to enhance clinical management decisions in pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography and computed tomography with [68Ga]Ga-fibroblast activation protein inhibitors improves tumor detection and staging in patients with pancreatic cancer. Pang, Y., Zhao, L., Shang, Q., et al.[2023]

In a study of 33 patients suspected of having pancreatic cancer, 68 Ga-FAPI-04 PET/MR showed equivalent detection rates for primary tumors compared to 18F-FDG PET/CT, but with significantly higher uptake values, indicating its potential for better tumor characterization.

68 Ga-FAPI-04 PET/MR was more effective in detecting suspicious lymph node metastases compared to 18F-FDG PET, while the latter was better at identifying liver metastases, suggesting that combining these imaging techniques could enhance overall diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the diagnostic efficacy of 68 Ga-FAPI-04 PET/MR and 18F-FDG PET/CT in patients with pancreatic cancer. Zhang, Z., Jia, G., Pan, G., et al.[2023]

The PET tracer 68Ga-FAPI-04 demonstrated high sensitivity for detecting hepatic malignancies in a study of 25 patients, with 28 malignant lesions identified, particularly in poorly differentiated cancers.

The tracer's effectiveness was correlated with elevated fibroblast activation protein (FAP) expression in the tumors, suggesting it could be a valuable tool for characterizing liver cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast imaging of hepatic carcinoma with 68Ga-FAPI-04 PET/CT: a pilot study in patients with suspected hepatic nodules. Shi, X., Xing, H., Yang, X., et al.[2021]

68Ga-FAPI-04 PET/CT demonstrated significantly higher sensitivity (98%) and comparable specificity (81%) compared to 18F-FDG PET/CT, which had a sensitivity of 73% and specificity of 77%, indicating its superior ability to detect primary digestive cancers.

This imaging technique was particularly effective for diagnosing gastric, liver, biliary tract, and pancreatic cancers, suggesting it may be a better option for early detection of these malignancies, although further high-quality studies are needed due to the small and heterogeneous sample sizes in the current analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT in the evaluation of primary digestive system cancer: a systematic review and meta-analysis. Ouyang, J., Ding, P., Zhang, R., et al.[2023]

68Ga-FAPI is a new PET imaging agent that shows promise for detecting tumors, indicating its potential utility in cancer diagnosis.

The study highlights the use of 68Ga-FAPI PET/CT imaging in a patient with Baastrup disease and esophageal cancer, suggesting that FAPI uptake may also be relevant in nonmalignant conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. Yang, X., Liu, Y., Chen, J., et al.[2023]

In a study of 103 patients using 68Ga-FAPI-04 PET/MR imaging, focal uptake of the tracer was found in the pancreas, indicating that it can occur in benign conditions such as pancreatic pseudocysts and prior pancreatitis, rather than just malignant tumors.

The findings suggest that while 68Ga-FAPI-04 is promising for cancer diagnosis, careful evaluation is necessary to avoid misdiagnosis, and the combination with MR imaging may help differentiate between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. Zhang, X., Song, W., Qin, C., et al.[2022]

Using half-dose [68Ga]Ga-FAPI-04 in total-body PET/CT imaging allows for a reduced acquisition time of 120 seconds while still achieving a 100% tumor detection rate in 27 patients, indicating its efficacy in diagnosing malignant tumors.

The image quality remains acceptable at this reduced dose and time, making it a safer option for radiation-sensitive populations, such as children and pregnant women, who may require shorter imaging sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. Chen, Z., Wang, Y., Yang, X., 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 involving a 55-year-old woman, 68Ga-FAPI PET/CT was more effective than 18F-FDG PET/CT in detecting pancreatic cancer metastases, revealing more abnormal foci in the mesentery and omentum.

Post-surgery follow-up with 68Ga-FAPI PET/CT showed a significant reduction in tracer activity, indicating a positive response to the cytoreductive surgery for acinar cell carcinoma of the pancreas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 68Ga-FAPI PET/CT for Evaluation of Peritoneal Carcinomatosis Before and After Cytoreductive Surgery. Zhao, L., Pang, Y., Wei, J., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The added value of [68Ga]Ga-DOTA-FAPI-04 PET/CT in pancreatic cancer: a comparison to [18F]F-FDG. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Positron emission tomography and computed tomography with [68Ga]Ga-fibroblast activation protein inhibitors improves tumor detection and staging in patients with pancreatic cancer. [2023]

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

Comparison of the diagnostic efficacy of 68 Ga-FAPI-04 PET/MR and 18F-FDG PET/CT in patients with pancreatic cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Fibroblast imaging of hepatic carcinoma with 68Ga-FAPI-04 PET/CT: a pilot study in patients with suspected hepatic nodules. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT in the evaluation of primary digestive system cancer: a systematic review and meta-analysis. [2023]

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

68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

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

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

Use of 68Ga-FAPI PET/CT for Evaluation of Peritoneal Carcinomatosis Before and After Cytoreductive Surgery. [2023]