Clinical trial NCT01383135: Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Official title: Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Non-Small-Cell Lung Cancer
Glioblastoma
Other Cancers
Keywords: Healthy volunteers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Tracer Dosimetry by Organ
timeFrame: 5 hours
measure: F18-FPPRGD2 Time-activity at Specified Timepoints
timeFrame: 30, 60, and 90 minutes post-injection
measure: Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer
timeFrame: 3 hours
measure: Specificity of F18 FPPRGD2 PET/CT in Breast Cancer
timeFrame: an estimated average of 3 hours
measure: Glioblastoma Primary Tumor Response Assessed by PET Scan
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Glioblastoma Primary Tumor Response Assessed by CT Scan
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sanjiv Gambhir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: