Trials / Completed
CompletedNCT01806675
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Sanjiv Sam Gambhir · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-03-04
- Primary completion
- 2016-12-07
- Completion
- 2019-04-01
- First posted
- 2013-03-07
- Last updated
- 2019-10-03
- Results posted
- 2019-09-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01806675. Inclusion in this directory is not an endorsement.