60 Participants Needed

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

(FAPI-46 PDAC Trial)

Recruiting at 3 trial locations
SM
BA
Overseen ByBridget Adams
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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 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.12345

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.23678

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.12348

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.

Eligibility Criteria

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.
See 3 more

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
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 68Ga-FAPI-46 PET/CTExperimental Treatment1 Intervention
Patients receive \[68Ga\]FAPI-46 intravenously followed by PET/CT 15-25 minutes later

Find a Clinic Near You

Who Is Running the Clinical Trial?

SOFIE

Lead Sponsor

Trials
2
Recruited
180+

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.
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.
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.
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]

References

The added value of [68Ga]Ga-DOTA-FAPI-04 PET/CT in pancreatic cancer: a comparison to [18F]F-FDG. [2023]
Positron emission tomography and computed tomography with [68Ga]Ga-fibroblast activation protein inhibitors improves tumor detection and staging in patients with pancreatic cancer. [2023]
Comparison of the diagnostic efficacy of 68 Ga-FAPI-04 PET/MR and 18F-FDG PET/CT in patients with pancreatic cancer. [2023]
Impact of 68Ga-FAPI PET/CT Imaging on the Therapeutic Management of Primary and Recurrent Pancreatic Ductal Adenocarcinomas. [2022]
Fibroblast imaging of hepatic carcinoma with 68Ga-FAPI-04 PET/CT: a pilot study in patients with suspected hepatic nodules. [2021]
68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]
Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]
Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas. [2022]
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