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

Sanjiv Sam Gambhir

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Drug: 18F-FPPRGD2; Drug: 18F-fludeoxyglucose (18F-FDG)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01806675

IRB-25970 (Other Identifier)

VARIMG0002 (Other Identifier)

NCI-2013-00535 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE

• Evaluate 18F-FPPRGD2 and 18F-FDG as PET/CT or PET/MRI radiotracers for imaging prediction and assessment of response to anti-angiogenesis therapy in participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC).

SECONDARY OBJECTIVE

• Progression-free survival (PFS) at up to 1 year after initial scans and treatment

OUTLINE:

Patients undergo 18F-FPPRGD2 and 18F-FDG PET/CT or PET/MRI medical imaging at baseline and at regular medical care follow-up (6 to 12 weeks).

After completion of study imaging, patients are followed up at 12 months.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 or treatment with other drugs that may alter angiogenesis
• Able to remain still for duration of each imaging procedure (about one hour)

Exclusion criteria

• Pregnant or nursing
• Contraindication to MRI
• History of renal insufficiency (only for MRI contrast administration)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Glioblastoma Multiforme (GBM)

Experimental group

Description:

Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)

Treatment:

Drug: 18F-fludeoxyglucose (18F-FDG)

Drug: 18F-FPPRGD2

Gynecological Cancers

Experimental group

Description:

Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)

Treatment:

Drug: 18F-fludeoxyglucose (18F-FDG)

Drug: 18F-FPPRGD2

Renal Cell Cancer (RCC)

Experimental group

Description:

Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)

Treatment:

Drug: 18F-fludeoxyglucose (18F-FDG)

Drug: 18F-FPPRGD2