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

Stanford University

Status and phase: Completed; Early Phase 1

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

Treatments: Drug: F18-FPPRGD2

Study type: Interventional

Funder types: Other

Identifiers

NCT01383135

VAR0047

SU-09022010-6791 (Other Identifier)

IRB-16118

Details and patient eligibility

About

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.

Full description

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

Healty Volunteers

Other group

Description:

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

Treatment:

Drug: F18-FPPRGD2

Breast Cancer

Experimental group

Description:

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

Treatment:

Drug: F18-FPPRGD2

Glioblastoma Multiform (brain)

Experimental group

Description:

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

Treatment:

Drug: F18-FPPRGD2

Lung Cancer

Experimental group

Description:

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

Treatment:

Drug: F18-FPPRGD2