[68Ga]FAPI-46 for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreatic Cancer+1 More[68Ga]FAPI-46 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Pancreatic Cancer
  • Familial Adenomatous Polyposis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Through study completion, 2 years

Year 2
[68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.
Year 2
Histopathology with FAP staining on FAP IHC assay.
Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.
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.
[68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.
Hour 24
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Brain Metastasis from HER2+ Breast Cancer
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1
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Trial Design

1 Treatment Group

68Ga-FAPI-46 PET/CT
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: [68Ga]FAPI-46 · No Placebo Group · Phase 2

68Ga-FAPI-46 PET/CT
Drug
Experimental Group · 1 Intervention: [68Ga]FAPI-46 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, 2 years

Who is running the clinical trial?

SOFIELead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are planned to undergo surgical resection or to receive neoadjuvant therapy (i.e.
Imaging obtained within 28 days of consent.
References

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