Overview

Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 Positron Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and healthy volunteers. Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers. [18F]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Sanjiv Sam Gambhir

Collaborator:

National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

Healthy volunteers:

1. Must be 18 years of age or older.

2. Must have no known medical problems and have had a full medical exam within 6 months
of the study. If healthy volunteers have not had a full medical exam within 6 months
of the study, one of the nuclear medicine physicians will conduct the medical exam
prior to any study procedures.

3. Must understand and voluntarily have signed an Informed Consent after its contents
have been fully explained.

4. Women of child bearing potential (as defined as women who are not post menopausal for
12 months or who have had no previous surgical sterilization) and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry, for the duration of study participation and for 30 days after
the last dose.

Pancreatic cancer subjects:

1. Participant must be 18 years or older at the time of radiotracer administration

2. Provides written informed consent

3. Suspected or established diagnosis of pancreatic cancer based on any radiographic scan
or pathology and who is scheduled for surgery OR Biopsy proven diagnosis of pancreatic
cancer who is no longer a surgical candidate

Exclusion Criteria:

Healthy volunteers:

1. Participant is less than 18 year-old

2. Pregnant or breast feeding women.

3. Patients who are not likely to comply with the protocol requirements.

Pancreatic cancer subjects:

1. Participant is pregnant or breast-feeding

2. Participant is not able to comply with the study procedures

3. Participant has serious uncontrolled concurrent medical illness that would limit
compliance with study requirements

4. Metallic implants (contraindicated for MRI)

5. History of renal insufficiency (only for MRI contrast administration)