Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

NCT ID: NCT01383135

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.

The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.

Detailed Description

The tracer [18F]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.

Conditions

Breast Cancer; Non-Small-Cell Lung Cancer; Glioblastoma; Other Cancers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healty Volunteers

Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.

Group Type: OTHER

F18-FPPRGD2

Intervention Type: DRUG

Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Breast Cancer

Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection.

Group Type: EXPERIMENTAL

F18-FPPRGD2

Intervention Type: DRUG

Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Glioblastoma Multiform (brain)

Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection.

Group Type: EXPERIMENTAL

F18-FPPRGD2

Intervention Type: DRUG

Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Lung Cancer

Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection.

Group Type: EXPERIMENTAL

F18-FPPRGD2

Intervention Type: DRUG

Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Interventions

F18-FPPRGD2

Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Intervention Type: DRUG

Eligibility 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.

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).

5. 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.

Cancer subjects:

1. Greater than 18 years-old at the time of radiotracer administration

2. Provides written informed consent

3. Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy

4. Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria

1. Less than 18 years-old at the time of radiotracer administration

2. Pregnant or nursing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjiv Gambhir, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-09022010-6791

Identifier Type: OTHER

Identifier Source: secondary_id

VAR0047

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-16118

Identifier Type: -

Identifier Source: org_study_id