18F FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
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 Breast Cancer - 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
Conditions: official terms
Breast Neoplasms - Breast Neoplasms, Male - Carcinoma - Carcinoma, Adenoid Cystic - Carcinoma, Basal Cell - Carcinoma, Mucoepidermoid - Carcinoma, Non-Small-Cell Lung - Carcinoma, Renal Cell - Carcinoma, Squamous Cell - Esthesioneuroblastoma, Olfactory - Glioblastoma - Gliosarcoma - Head and Neck Neoplasms - Hypopharyngeal Neoplasms - Lip Neoplasms - Lung Neoplasms - Mouth Neoplasms - Neoplasms, Unknown Primary - Oropharyngeal Neoplasms - Pancreatic Neoplasms - Papilloma, Inverted - Rectal Neoplasms - Salivary Gland Neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: fludeoxyglucose F 18 Type: Radiation
Name: 2-fluoropropionyl-labeled pegylated dimeric RGD peptide Type: Radiation
Name: positron emission tomography Type: Procedure
Name: computed tomography Type: Procedure
Name: positron emission tomography Type: Procedure
Name: computed tomography Type: Procedure
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
Summary
The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. We will assess the uptake of this novel radiopharmaceutical in subjects with breast cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring antiangiogenesis treatment.
Detailed Description
PRIMARY OBJECTIVES:

I. Evaluate 18F FPPRGD2 PET/CT or PET/MRI for prediction and early assessment of response to anti-angiogenesis therapy in patients with non-small cell lung cancer (NSCLC), breast cancer, glioblastoma multiforme (GBM) and other cancers.

OUTLINE:

Patients undergo 18F FPPRGD2 PET/CT or PET/MRI at baseline, 1 week, and 6 weeks (or standard of care follow-up) and 18F FDG PET/CT at baseline and 6 weeks (or standard of care follow-up) .

After completion of study imaging, patients are followed up at 12 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Provides written informed consent

- Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment

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

Exclusion Criteria:

- Pregnant or nursing
Location
Stanford University Cancer Institute
Stanford, California, United States
Status: Recruiting
Contact: Krithika Rupnarayan, MD - 650-725-4712 - krupnara@stanford.edu
Start Date
March 2013
Completion Date
March 2019
Sponsors
Sanjiv Sam Gambhir
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page