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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University
ClinicalTrials.gov Identifier:
NCT01806675
First received: March 5, 2013
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

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.


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 or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis

Resource links provided by NLM:


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: 150
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 or PET/MRI)
Patients undergo 18F FPPRGD2 PET/CT or PET/MRI imaging 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) .
Radiation: fludeoxyglucose F 18
Undergo 18F FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Radiation: 2-fluoropropionyl-labeled pegylated dimeric RGD peptide
Undergo 18F FPPRGD2 PET/CT or PET/MRI
Other Names:
  • 104150
  • 18F-FPPRGD2
  • [18F] FPPRGD2
  • fluorine 18 ((18)F) FPPRGD2
  • PEG3-E[c(RGDyk)]2
Procedure: positron emission tomography
Undergo 18F FPPRGD2 PET/CT or PET/MRI
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
  • magnetic resonance imaging
Procedure: computed tomography
Undergo 18F FPPRGD2 PET/CT or PET/MRI
Other Names:
  • tomography, computed
  • magnetic resonance imaging
Procedure: positron emission tomography
Undergo 18F FDG PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806675

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Krithika Rupnarayan, MD    650-725-4712    krupnara@stanford.edu   
Contact: Andrei Iagaru, MD    650-736 2859    aiagaru@stanford.edu   
Principal Investigator: Sanjiv Gambhir, MD, PhD         
Sub-Investigator: Andrei Iagaru, MD         
Sponsors and Collaborators
Sanjiv Sam Gambhir
Investigators
Principal Investigator: Sanjiv Gambhir Stanford University
  More Information

No publications provided

Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, 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: October 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Squamous Cell
Rectal Neoplasms
Glioblastoma
Head and Neck Neoplasms
Colonic Neoplasms
Pancreatic Neoplasms
Carcinoma, Renal Cell
Carcinoma, Basal Cell
Salivary Gland Neoplasms
Gliosarcoma
Carcinoma, Adenoid Cystic
Neoplasms, Unknown Primary
Breast Neoplasms, Male
Carcinoma, Mucoepidermoid
Esthesioneuroblastoma, Olfactory
Papilloma, Inverted
Mouth Neoplasms
Hypopharyngeal Neoplasms
Breast Neoplasms
Carcinoma
Neoplasms
Oropharyngeal Neoplasms
Lip Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014