18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

NCT01806675 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-10-03

Study results available
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Summary

The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.

Conditions

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Male Breast Cancer
  • Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Recurrent Adult Brain Tumor
  • Recurrent Basal Cell Carcinoma of the Lip
  • Recurrent Colon Cancer
  • Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Hypopharyngeal Cancer
  • Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Laryngeal Cancer
  • Recurrent Lip and Oral Cavity Cancer
  • Recurrent Lymphoepithelioma of the Nasopharynx
  • Recurrent Lymphoepithelioma of the Oropharynx
  • Recurrent Metastatic Squamous Neck Cancer With Occult Primary
  • Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
  • Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
  • Recurrent Nasopharyngeal Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Recurrent Oropharyngeal Cancer
  • Recurrent Pancreatic Cancer
  • Recurrent Paranasal Sinus and Nasal Cavity Cancer
  • Recurrent Rectal Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Salivary Gland Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV Pancreatic Cancer
  • Stage IV Renal Cell Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVA Salivary Gland Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Salivary Gland Cancer
  • Stage IVC Salivary Gland Cancer
  • Tongue Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

18F-fludeoxyglucose (18F-FDG)

18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan

DRUG

18F-FPPRGD2

18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Sanjiv Sam Gambhir

    lead OTHER

Principal Investigators

  • Sanjiv Gambhir, MD, PhD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-04
Primary Completion
2016-12-07
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01806675 on ClinicalTrials.gov