18F FPPRGD2 Positron Emission Tomography/Computed Tomography in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
This study is currently recruiting participants.
Verified March 2013 by Stanford University
Sponsor:
Stanford University
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01806675
First received: March 5, 2013
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
This phase I/II trial studies fluorine 18 2-fluoropropionyl-labeled pegylated dimeric arginine-glycine-aspartic acid (RGD) peptide (18F FPPRGD2) positron emission tomography (PET)/computed tomography (CT) in predicting early response in patients with cancer receiving anti-angiogenesis therapy. Diagnostic procedures, such as 18F FPPRGD2 PET/CT, may be a less invasive method of finding cancer early and determining response to treatment
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Radiation: fludeoxyglucose F 18 Radiation: 2-fluoropropionyl-labeled pegylated dimeric RGD peptide Procedure: positron emission tomography Procedure: computed tomography Other: laboratory biomarker analysis |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Phase I/II 18F FPPRGD2 PET/CT Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis |
Resource links provided by NLM:
MedlinePlus related topics:
Benign Tumors
Brain Cancer
Breast Cancer
CT Scans
Cancer
Lung Cancer
Male Breast Cancer
Nuclear Scans
Oral Cancer
Pancreatic Cancer
Tonsils and Adenoids
Drug Information available for:
Fludeoxyglucose F 18
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Change in maximum standard uptake values (SUVmax) on 18F FPPRGD2 and 18F FDG PET [ Time Frame: From baseline up to 6 weeks ] [ Designated as safety issue: No ]Response to treatment is based on the change in PET uptake, change in CT tumor size, PET European Organization for Research and Treatment of Cancer (EORTC) response criteria, and CT Response Evaluation Criteria In Solid Tumors (RECIST) response criteria. Each of the four response criteria will be dichotomized into responding or non-responding to treatment. The Mann-Whitney test and logistic regression of response/non-response will be performed.
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]For each SUV measure patients will be divided into two groups based on whether their SUV uptake is above or below the median. Kaplan-Meir curves for the two groups will be plotted and a log-rank test for difference in PFS will be performed. A Cox proportional-hazards regression of PFS on group will be performed.
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diagnostic (18F FPPRGD2 PET/CT)
Patients undergo 18F FPPRGD2 PET/CT imaging at baseline, 1 week, and 6 weeks and 18F FDG PET/CT at baseline and 6 weeks.
|
Radiation: fludeoxyglucose F 18
Undergo 18F FDG PET/CT
Other Names:
Radiation: 2-fluoropropionyl-labeled pegylated dimeric RGD peptide
Undergo 18F FPPRGD2 PET/CT
Other Names:
Procedure: positron emission tomography
Undergo 18F FPPRGD2 PET/CT
Other Names:
Procedure: computed tomography
Undergo 18F FPPRGD2 PET/CT
Other Name: tomography, computed
Procedure: positron emission tomography
Undergo 18F FDG PET/CT
Other Names:
Procedure: computed tomography
Undergo 18F FDG PET/CT
Other Name: tomography, computed
Other: laboratory biomarker analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
I. Evaluate 18F FPPRGD2 PET/CT 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 imaging at baseline, 1 week, and 6 weeks and 18F FDG PET/CT at baseline and 6 weeks.
After completion of study imaging, patients are followed up at 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806675
Contacts
| Contact: Jonathan Euodia | 650-723-7419 | euodia@stanford.edu |
Locations
| United States, California | |
| Stanford University Cancer Institute | Recruiting |
| Stanford, California, United States, 94305 | |
| Principal Investigator: Sanjiv Gambhir | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Sanjiv Gambhir | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01806675 History of Changes |
| Other Study ID Numbers: | VARIMG0002, NCI-2013-00535 |
| Study First Received: | March 5, 2013 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Tongue Neoplasms Brain Neoplasms Breast Neoplasms Carcinoma Colonic Neoplasms Laryngeal Neoplasms Rectal Neoplasms Carcinoma, Basal Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Adenoid Cystic Glioblastoma Granuloma Lung Neoplasms |
Mouth Neoplasms Pancreatic Neoplasms Papilloma Oropharyngeal Neoplasms Nasopharyngeal Neoplasms Hypopharyngeal Neoplasms Carcinoma, Mucoepidermoid Esthesioneuroblastoma, Olfactory Papilloma, Inverted Gliosarcoma Head and Neck Neoplasms Neoplasms, Unknown Primary Salivary Gland Neoplasms Lip Neoplasms Breast Neoplasms, Male |
ClinicalTrials.gov processed this record on May 22, 2013