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

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ClinicalTrials.gov Identifier: NCT01806675
Recruitment Status : Active, not recruiting
First Posted : March 7, 2013
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

Tracking Information
First Submitted Date  ICMJE March 5, 2013
First Posted Date  ICMJE March 7, 2013
Last Update Posted Date June 5, 2018
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01806675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Official Title  ICMJE Phase I/II 18F FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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) .
Interventions:
  • Drug: fludeoxyglucose F 18
  • Drug: 2-fluoropropionyl-labeled pegylated dimeric RGD peptide
  • Diagnostic Test: positron emission tomography
  • Diagnostic Test: computed tomography
  • Diagnostic Test: positron emission tomography
  • Diagnostic Test: computed tomography
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 3, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)
100
Estimated Study Completion Date  ICMJE March 2019
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806675
Other Study ID Numbers  ICMJE VARIMG0002
NCI-2013-00535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanjiv Sam Gambhir, Stanford University
Study Sponsor  ICMJE Sanjiv Sam Gambhir
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sanjiv Gambhir Stanford University
PRS Account Stanford University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP