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

NCT01383135 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: IRB-16118SU-09022010-6791VAR0047
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (5)

• Tracer Dosimetry by Organ

  Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003). Results are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.

  5 hours

• F18-FPPRGD2 Time-activity at Specified Timepoints

  Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time.

  30, 60, and 90 minutes post-injection

• Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer

  Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as \[TP/ (TP+FN)\], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result.

  3 hours

• Specificity of F18 FPPRGD2 PET/CT in Breast Cancer

  Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is: \[TN/ (TN+FP)\], where TN= true negative, and FP = false positive.

  an estimated average of 3 hours

• Glioblastoma Primary Tumor Response Assessed by PET Scan

  Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation.

  Baseline and Week 6

Secondary Outcomes (1)

• Glioblastoma Primary Tumor Response Assessed by CT Scan

  Baseline and Week 6

Study Arms (4)

Healty Volunteers

OTHER

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

Drug: F18-FPPRGD2

Breast Cancer

EXPERIMENTAL

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

Drug: F18-FPPRGD2

Glioblastoma Multiform (brain)

EXPERIMENTAL

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

Drug: F18-FPPRGD2

Lung Cancer

EXPERIMENTAL

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

Drug: F18-FPPRGD2

Interventions

F18-FPPRGD2 DRUG

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

Breast Cancer; Glioblastoma Multiform (brain); Healty Volunteers; Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers:
• Must be 18 years of age or older.
• Must have no known medical problems and have had a full medical exam within 6 months of the study.
• Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
• 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).
• 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:
• Greater than 18 years-old at the time of radiotracer administration
• Provides written informed consent
• Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy
• Able to remain still for duration of each imaging procedure (about one hour)

You may not qualify if:

• Less than 18 years-old at the time of radiotracer administration
• Pregnant or nursing

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Limitations and Caveats

This study is a pilot study.

Results Point of Contact

• Title: Andrei Iagaru, MD
• Organization: Stanford University

aiagaru@stanford.edu

6507362859

Study Officials

• Sanjiv Gambhir, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 28, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)