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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.
Verified March 2017 by Sanjiv Sam Gambhir, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806675
First Posted: March 7, 2013
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University
  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 Drug: fludeoxyglucose F 18 Drug: 2-fluoropropionyl-labeled pegylated dimeric RGD peptide Diagnostic Test: positron emission tomography Diagnostic Test: computed tomography Other: laboratory biomarker analysis Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Sanjiv Sam Gambhir, 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 ]
    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 ]
    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) .
Drug: fludeoxyglucose F 18
Undergo 18F FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Drug: 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
Diagnostic Test: positron emission tomography
Undergo 18F FPPRGD2 PET/CT or PET/MRI
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
  • magnetic resonance imaging
Diagnostic Test: computed tomography
Undergo 18F FPPRGD2 PET/CT or PET/MRI
Other Names:
  • tomography, computed
  • magnetic resonance imaging
Diagnostic Test: positron emission tomography
Undergo 18F FDG PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Diagnostic Test: 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806675


Contacts
Contact: Krithika Rupnarayan 650-736-0959 krupnara@stanford.edu

Locations
United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Krithika Rupnarayan    650-736-0959    krupnara@stanford.edu   
Principal Investigator: Sanjiv Gambhir, MD, PhD         
Sub-Investigator: Andrei Iagaru, MD         
Sponsors and Collaborators
Sanjiv Sam Gambhir
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sanjiv Gambhir Stanford University
  More Information

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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 5, 2013
First Posted: March 7, 2013
Last Update Posted: March 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Pancreatic Neoplasms
Glioblastoma
Rectal Neoplasms
Head and Neck Neoplasms
Colonic Neoplasms
Carcinoma, Renal Cell
Carcinoma, Basal Cell
Gliosarcoma
Salivary Gland Neoplasms
Papilloma
Carcinoma, Adenoid Cystic
Neoplasms, Unknown Primary
Breast Neoplasms, Male
Carcinoma, Mucoepidermoid
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Granuloma
Esthesioneuroblastoma, Olfactory
Papilloma, Inverted
Laryngeal Neoplasms
Mouth Neoplasms
Hypopharyngeal Neoplasms
Tongue Neoplasms
Lip Neoplasms
Neoplasms, Glandular and Epithelial