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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a special PET/CT scan technique to help doctors better visualize pancreatic cancer. The scan uses a compound called 68Ga-FAPI-46 (Gallium Ga 68 FAPi-46), which highlights connective tissue cells often associated with pancreatic cancer, making the cancer easier to detect on scans. The trial aims to improve the diagnosis and treatment of pancreatic ductal adenocarcinoma (a type of pancreatic cancer) that hasn't spread. It is suitable for adults with newly diagnosed, localized pancreatic cancer who plan to undergo surgery after initial treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to advancements in cancer diagnosis and treatment.

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 prior data suggests that this PET/CT scan is safe for imaging pancreatic cancer?

Research has shown that the 68Ga-FAPI-46 PET/CT scan effectively detects certain cancer cells. This scan uses a special substance, 68Ga-FAPI-46, which binds to specific proteins in cancer cells.

In studies using this substance, it identified cancerous areas that other scans might miss. So far, patients have generally tolerated the scan well, with few reports of serious side effects.

Since this scan is in a phase 2 trial, earlier tests have already demonstrated some safety. This suggests the scan is expected to be safe, but researchers continue to monitor for any possible issues. Overall, the scan's history indicates it is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 68Ga-FAPI-46 PET/CT scan for pancreatic cancer because it offers a novel way to visualize tumors. Unlike traditional imaging methods like standard CT or MRI scans, this technique uses a radiotracer, 68Ga-FAPI-46, that targets fibroblast activation protein, which is often overexpressed in cancerous tissues. This targeted approach can provide clearer and more detailed images of the cancer, potentially leading to better diagnosis and monitoring of the disease. Additionally, this method may be more sensitive in detecting cancerous lesions, which could improve treatment planning and outcomes for patients.

What evidence suggests that this PET/CT scan is effective for imaging pancreatic cancer?

Research has shown that 68Ga-FAPI-46 PET/CT scans, which participants in this trial will undergo, are promising for detecting pancreatic cancer. Studies have found that this method excels at identifying primary pancreatic tumors and affected lymph nodes compared to some other imaging techniques. The scan targets a protein called fibroblast activation protein (FAP), abundant around cancer cells, making tumors easier to detect. In other cancers, like sarcoma, this imaging method consistently identified cancer with high accuracy. These findings suggest that 68Ga-FAPI-46 PET/CT could enhance the diagnosis and treatment of pancreatic cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

Ajit H. Goenka, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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]

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]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/65/7/1027

Prognostic Implications of 68 Ga-FAPI-46 PET/CT–Derived ... Disease extent on 68 Ga-FAPI-46 PET/CT is a predictor of short OS and may aid in future risk stratification by playing a supplemental role alongside 18 F-FDG ...

2. nature.com nature.com/articles/s41598-023-43049-2

Comparison of early and late 68Ga-FAPI-46-PET in 33 ... In addition, a recent study demonstrated that 68Ga-FAPI-PET shows higher sensitivity in detecting primary pancreatic tumors, involved lymph ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10681241/

Gallium-68-labeled fibroblast activation protein inhibitor-46 ... Efficacy analysis. Primary efficacy analyses. The primary efficacy endpoints will compare the results from [68Ga]FAPI-46 PET and histopathology.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05518903

NCT05518903 | Investigational Scan (68Ga-FAPI-46 PET/ ... This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.457

68Ga-FAPI-46 PET/CT for cancer imaging: Results of a ... Patient-based PPV/SE for 68Ga-FAPI-46 (18F-FDG) PET were 94/72% (97/71%) for GU cancers, 100/96% (100/96%) for sarcoma, and 100/91% (100/88%) ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/64/8/1232

Tumor Characterization by [ 68 Ga]FAPI-46 PET/CT Can ... We conclude that [ 68 Ga]FAPI-46 PET/CT can accurately differentiate malignant from benign pancreatic lesions deemed equivocal by standard-of-care imaging.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40774265/

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ... We aim to investigate the positive predictive value (PPV) of [68Ga]Ga-FAPI-46 PET for detecting FAP-expressing tumours and the potential ...