[68Ga]FAPI-46 PET Scan for Pancreatic Cancer

(FAPI-46 PDAC Trial)

No longer recruiting at 3 trial locations

Overseen By Bridget Adams

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SOFIE

Must not be taking: Investigational agents

Disqualifiers: Pregnancy, Infections, Autoimmune disorders, others

Stay on Your Current Meds You can continue your current medications while participating

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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new PET scan using [68Ga]FAPI-46 detects pancreatic cancer cells in patients planning surgery. The scan targets specific markers on cancer cells to enhance doctors' understanding of the cancer. Individuals with pancreatic ductal adenocarcinoma, who have not yet begun treatment and are scheduled for surgery or pre-surgery therapy, may be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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

What prior data suggests that the [68Ga]FAPI-46 PET scan is safe for detecting pancreatic cancer?

Research shows that [68Ga]FAPI-46 is generally safe for use in humans as a tool to detect cancer. Studies have confirmed its safety and ability to identify tumors that express FAP, making it effective at pinpointing certain cancer cells.

Although the specific phase of the trial available isn't mentioned, earlier stages have already tested this treatment, suggesting it is likely well-tolerated. Previous research has not widely reported major side effects.

In summary, [68Ga]FAPI-46 is considered safe based on current studies, with safety being a key focus in its development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [68Ga]FAPI-46 for pancreatic cancer because it offers a new way to visualize tumors using PET/CT scans. Unlike traditional imaging methods, which often rely on glucose uptake and can be less effective in pancreatic cancer, [68Ga]FAPI-46 targets fibroblast activation protein, which is abundant in cancer-associated fibroblasts. This means it could provide clearer, more accurate images of tumors, helping doctors to better diagnose and plan treatment. The ability to capture detailed images just 15-25 minutes after administration is another potential advantage, enhancing the efficiency of the diagnostic process.

What evidence suggests that the [68Ga]FAPI-46 PET scan is effective for detecting pancreatic cancer?

Research has shown that \[68Ga\]FAPI-46 PET scans, which participants in this trial will undergo, are promising for spotting pancreatic cancer cells. Studies have found that this scan better identifies cancerous tissue than the standard \[18F\] FDG PET scan. One study showed that \[68Ga\]FAPI-46 had a sensitivity of 96% and a specificity of 92%, both high. This means it can accurately detect cancer in most cases and avoid false alarms. Additionally, \[68Ga\]FAPI-46 PET/CT scans can distinguish between cancerous and non-cancerous pancreatic growths, ensuring an accurate diagnosis. Overall, these findings suggest this imaging method could effectively detect and assess pancreatic cancer. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with confirmed pancreatic ductal adenocarcinoma that's treatable by surgery or might be after neoadjuvant therapy. They must have had recent imaging and not started treatment yet. Excluded are pregnant individuals, those not using contraception, anyone needing urgent surgery, people with serious illnesses like kidney or liver failure, autoimmune diseases, known allergies to [68Ga]FAPI-46 components, or active infections.

Inclusion Criteria

You have been diagnosed with pancreatic ductal adenocarcinoma through a biopsy or surgery.

Completed informed consent as determined per the IRB of record

Your cancer is able to be surgically removed or almost able to be surgically removed.

Exclusion Criteria

Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential

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

Need for emergent surgery that would be delayed by participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial PET Scan

Participants undergo an initial [68Ga]FAPI-46 PET scan after staging using institutional standard methods

1 day

1 visit (in-person)

Neoadjuvant Therapy and Second PET Scan

If prescribed, participants receive neoadjuvant therapy followed by a second [68Ga]FAPI-46 PET scan within 21 days prior to planned surgical resection

Variable, up to 21 days

1 visit (in-person)

Surgical Resection and Analysis

Participants undergo surgical resection followed by histopathology and IHC analyses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [68Ga]FAPI-46

Trial Overview [68Ga]FAPI-46 PET scans are being tested for their ability to detect specific cancer cells in patients with resectable pancreatic cancer. Participants will undergo these scans after initial staging and possibly again before surgical resection if they receive neoadjuvant therapy.

How Is the Trial Designed?

Group I: 68Ga-FAPI-46 PET/CT Experimental Treatment 1 Intervention

Patients receive \[68Ga\]FAPI-46 intravenously followed by PET/CT 15-25 minutes later

Who Is Running the Clinical Trial?

SOFIE

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

Citations

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

Gallium-68-labeled fibroblast activation protein inhibitor-46 ... A baseline PET scan will be conducted from the vertex to mid-thighs approximately 15 minutes after administering 5 mCi (±2) of [68Ga]FAPI-46 ...

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. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02835-x

a meta-analysis of [68ga] FAPI- 46 vs. [18f] FDG imaging This study revealed that [68Ga] FAPI- 46 outperforms [18F] FDG in cancer diagnosis, with higher sensitivity (0.96 vs. 0.73) and specificity (0.92 vs. 0.83).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37348917/

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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0001299823000922

How to Perform FAPI PET? An Expedited Systematic ... An injection-to-scan-time of 60 minutes was dominant for all FAPI PET studies. A possible trend toward shorter injection-to-scan times was observed for [68Ga]Ga ...

6. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00299-2/fulltext

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ... These results confirm the safety and potential of [68Ga]Ga-FAPI-46 PET as an imaging biomarker for the detection of FAP-expressing tumours.

7. 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.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0294564

Gallium-68-labeled fibroblast activation protein inhibitor-46 ... The drug product contains 0.1 mCi/ml to 5.0 mCi/ml [68Ga]FAPI-46 at the end-of-synthesis, 11.81 mg/m sodium acetate and 0.49 mg/mL sodium ...