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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate the biodistribution and safety of \[18F\]FP-R01-MG-F2 in healthy volunteers.

II. Evaluate the feasibility of \[18F\]FP-R01-MG-F2 PET/CT scanning in patients with pancreatic cancer.

OUTLINE:

Patients receive \[18F\]FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MR scan immediately after and at 60 and 120 minutes. Patients will be followed up at 24-48 hours.

Conditions

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Healthy Subject Pancreatic Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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pancreatic cancer patients

Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo CT scan

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

PET/MRI scan

Intervention Type DIAGNOSTIC_TEST

Undergo PET/MRI scan

[18F]FP-R01-MG-F2

Intervention Type DRUG

radioactive tracer

healthy patients

Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo CT scan

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

PET/MRI scan

Intervention Type DIAGNOSTIC_TEST

Undergo PET/MRI scan

[18F]FP-R01-MG-F2

Intervention Type DRUG

radioactive tracer

Interventions

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Computed Tomography

Undergo CT scan

Intervention Type DIAGNOSTIC_TEST

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

PET/MRI scan

Undergo PET/MRI scan

Intervention Type DIAGNOSTIC_TEST

[18F]FP-R01-MG-F2

radioactive tracer

Intervention Type DRUG

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Positron Emission Tomography Scan Positron-Emission Tomography magnetic resonance imaging

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes