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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 : Completed
First Posted : March 7, 2013
Results First Posted : September 6, 2019
Last Update Posted : October 3, 2019
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
Results First Submitted Date  ICMJE August 14, 2019
Results First Posted Date  ICMJE September 6, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE March 4, 2013
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2019)
Change From Baseline in Maximum Standard Uptake Values (SUVmax) [ Time Frame: At baseline and 6 weeks ]
Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.
Original 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2019)
  • Response Assessment by RANO Criteria [ Time Frame: At baseline and 6 weeks ]
    The treatment effect for participants with glioblastoma multiforme was to be assessed on the basis of post-treatment evaluation per the Response Assessment in Neuro-Oncology (RANO) Criteria. The outcome was the number & proportion of participants that achieved either a complete response (CR) or partial response (PR), a number without dispersion. RANO criteria are: CR= No T1 gadolinium (T1-G); T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) stable/decreased, no new lesions; no corticosteroids; clinical condition improved/stable. PR= ≥50% decrease in T1-G; T2/FLAIR decreased/stable ; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Stable disease (SD)= <50% decrease, but more than 25% increase, in T1-G; T2/FLAIR decreased/stable; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Progressive disease (PD)= ≥25%increase T1-G; T2/FLAIR increased; increased corticosteroids; clinical condition decreased
  • Change in Tumor Size [ Time Frame: 9 to 12 weeks ]
    The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.
  • Tumor Response Rate by EORTC Criteria [ Time Frame: At baseline and 6 weeks ]
    Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 & 18F-FDG at baseline & after 6 weeks of treatment, per European Organization for Research & Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), & progressive disease (PD).
    • CR= complete resolution of 18F-FDG uptake tumor volume
    • PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after >1 cycle
    • SD= increase in tumor 18F-FDG SUVmax of <25% or a decrease of <15% & no increase in 18F-FDG tumor uptake [>20% in the longest dimension (LD)];
    • PD= increase in 18F-FDG tumor SUVmax of >25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions
  • Progression-free Survival (PFS) [ Time Frame: 1 year ]
    Progression-free survival (PFS) was defined as remaining alive at 1 year with disease progression, according to the physician's assessment of clinical status, by disease group.
Original 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.
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 1-2 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. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
All human subject participants were to be evaluated with both 18F-FPPRGD2 PET/CT and 18-FDG PET/CT imaging scans.
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 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: 18F-fludeoxyglucose (18F-FDG)
    18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
    Other Names:
    • Fludeoxyglucose F-18
    • 18-FDG
    • FDG
  • 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.
    Other Names:
    • (18F)-2-fluoropropionyl-labeled PEGylated dimeric arginine-glycine-aspartic acid peptide
    • [PEG3-E{c(RGDyk)}2]
    • fluorine-18-FPPRGD2
    • [18F]-FPPRGD2
    • 2-fluoropropionyl-labeled pegylated dimeric RGD peptide
    • 104150
Study Arms  ICMJE
  • Experimental: Glioblastoma Multiforme (GBM)
    Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)
    Interventions:
    • Drug: 18F-fludeoxyglucose (18F-FDG)
    • Drug: 18F-FPPRGD2
  • Experimental: Gynecological Cancers
    Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
    Interventions:
    • Drug: 18F-fludeoxyglucose (18F-FDG)
    • Drug: 18F-FPPRGD2
  • Experimental: Renal Cell Cancer (RCC)
    Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
    Interventions:
    • Drug: 18F-fludeoxyglucose (18F-FDG)
    • Drug: 18F-FPPRGD2
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)
100
Actual Study Completion Date  ICMJE April 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 or treatment with other drugs that may alter angiogenesis
  • Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

  • Pregnant or nursing
  • Contraindication to MRI
  • History of renal insufficiency (only for MRI contrast administration)
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 IRB-25970
NCI-2013-00535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-25970 ( Other Identifier: Stanford IRB )
VARIMG0002 ( Other Identifier: OnCore ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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, MD, PhD Stanford University
PRS Account Stanford University
Verification Date September 2019

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