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[68Ga]FAPI-46 PET Scan for Pancreatic Cancer (FAPI-46 PDAC Trial)
Phase 2
Recruiting
Research Sponsored by SOFIE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 2 years
Awards & highlights
FAPI-46 PDAC Trial Summary
This trial is testing a new way to detect FAP-expressing cells in patients with pancreatic cancer. The new method uses a PET scan with [68Ga]FAPI-46.
Who is the study for?
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.Check my eligibility
What is being tested?
[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.See study design
What are the potential side effects?
The trial description does not specify side effects of [68Ga]FAPI-46; however, as it is a diagnostic agent used in PET scanning rather than a therapeutic drug, typical side effects may include allergic reactions to the compound or discomfort from the procedure.
FAPI-46 PDAC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.
Secondary outcome measures
Histopathology with FAP staining on FAP IHC assay.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Positive and negative predictive values, as well as accuracy of [68Ga]FAPI-46 PET images, to detect FAP-expressing cells using histopathology as truth standard.
+2 moreFAPI-46 PDAC Trial Design
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
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Who is running the clinical trial?
SOFIELead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with pancreatic ductal adenocarcinoma through a biopsy or surgery.You have been diagnosed with an autoimmune disorder.Your cancer is able to be surgically removed or almost able to be surgically removed.You are allergic to any of the ingredients used in the medication [68Ga]FAPI-46.You have a bacterial, viral, or fungal infection that needs strong medicine to treat.You need to have a CT or MRI scan done within 28 days before agreeing to participate.You have not received any previous treatment for this condition.You are planning to have surgery or receive treatment before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: 68Ga-FAPI-46 PET/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively involved in this research project?
"Affirmative. According to information published on clinicaltrials.gov, this study was officially posted on the 2nd of May 2022 and most recently updated on the 3rd of November 2022. It is currently looking for 60 patients from two separate sites."
Answered by AI
Is [68Ga]FAPI-46 a safe alternative for individuals?
"Our appraisal at Power granted [68Ga]FAPI-46 a score of 2, denoting that it is in Phase 2 with some evidence of safety but no proof yet of efficacy."
Answered by AI
Is this trial actively seeking participants?
"Clinicaltrials.gov reports that recruitment for this trial is ongoing and it was first published on May 2nd, 2022 before being revised most recently on November 3rd of the same year."
Answered by AI
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