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

Healthy Subject Clinical Trial

Official title:

Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683824
• Other study ID #: IRB-34376
• Secondary ID: NCI-2015-0188745
• Status: Completed
• Phase: Early Phase 1
• Start date: January 12, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2022
• Est. primary completion date: September 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Subject
• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Computed Tomography
Undergo CT scan

Other:
• Laboratory Biomarker Analysis
Correlative studies

Diagnostic Test:
• PET/MRI scan
Undergo PET/MRI scan

Drug:
• [18F]FP-R01-MG-F2
radioactive tracer

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodistribution of [18F]FP-R01-MG-F2 (%ID/g)	From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in percent injected dose per gram of tissue (%ID/g). ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle.	Up to 3 hours after tracer injection
Primary	Biodistribution of [18F]FP-R01-MG-F2 (SUV)	From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in Standardized Uptake Values (SUV). ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle.	Up to 3 hours after tracer injection
Primary	Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi)	Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software. These data will be reported in rem/mCi.	Up to 3 hours after tracer injection
Primary	Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq)	Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software. These data will be reported in mSv/MBq.	Up to 3 hours after tracer injection