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

(FAPI-46 PDAC Trial)

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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

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.

Is [68Ga]FAPI-46 PET scan safe for humans?

The studies on 68Ga-FAPI, a similar compound, suggest it is generally safe for imaging tumors and other conditions, but caution is advised as non-malignant uptake can occur, which may affect diagnosis. ^{1 2 3 4 5}

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

[68Ga]FAPI-46 PET scan is unique because it targets fibroblast activation protein (FAP), which is commonly found in the stroma of pancreatic tumors, allowing for improved tumor detection and staging compared to traditional imaging methods like [18F]FDG PET/CT. This can lead to more accurate diagnosis and potentially alter treatment plans for patients with pancreatic cancer. ^{3 4 5 6 7}

What data supports the effectiveness of the treatment [68Ga]FAPI-46 for pancreatic cancer?

Research shows that [68Ga]FAPI-46 PET/CT scans can improve the detection and staging of pancreatic cancer compared to traditional methods, leading to changes in treatment plans for some patients. This suggests that [68Ga]FAPI-46 may be effective in providing more accurate information about the cancer's spread, which can help doctors make better treatment decisions. ^{4 5 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 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 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 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 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]

Citations

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

Impact of 68Ga-FAPI PET/CT Imaging on the Therapeutic Management of Primary and Recurrent Pancreatic Ductal Adenocarcinomas. [2022]

5. 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]

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

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

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

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