18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
NCT ID: NCT01806675
Last Updated: 2019-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2013-03-04
2019-04-30
Brief Summary
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Detailed Description
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• 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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)
18F-fludeoxyglucose (18F-FDG)
18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
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.
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)
18F-fludeoxyglucose (18F-FDG)
18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
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.
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)
18F-fludeoxyglucose (18F-FDG)
18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
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.
Interventions
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18F-fludeoxyglucose (18F-FDG)
18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindication to MRI
* History of renal insufficiency (only for MRI contrast administration)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sanjiv Sam Gambhir
OTHER
Responsible Party
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Sanjiv Sam Gambhir
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research
Principal Investigators
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Sanjiv Gambhir, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University, School of Medicine
Stanford, California, United States
Countries
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References
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Minamimoto R, Jamali M, Barkhodari A, Mosci C, Mittra E, Shen B, Chin F, Gambhir SS, Iagaru A. Biodistribution of the (1)(8)F-FPPRGD(2) PET radiopharmaceutical in cancer patients: an atlas of SUV measurements. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1850-8. doi: 10.1007/s00259-015-3096-4. Epub 2015 Jun 11.
Iagaru A, Mosci C, Mittra E, Zaharchuk G, Fischbein N, Harsh G, Li G, Nagpal S, Recht L, Gambhir SS. Glioblastoma Multiforme Recurrence: An Exploratory Study of (18)F FPPRGD2 PET/CT. Radiology. 2015 Nov;277(2):497-506. doi: 10.1148/radiol.2015141550. Epub 2015 May 12.
Minamimoto R, Karam A, Jamali M, Barkhodari A, Gambhir SS, Dorigo O, Iagaru A. Pilot prospective evaluation of (18)F-FPPRGD2 PET/CT in patients with cervical and ovarian cancer. Eur J Nucl Med Mol Imaging. 2016 Jun;43(6):1047-55. doi: 10.1007/s00259-015-3263-7. Epub 2015 Nov 27.
Toriihara A, Duan H, Thompson HM, Park S, Hatami N, Baratto L, Fan AC, Iagaru A. 18F-FPPRGD2 PET/CT in patients with metastatic renal cell cancer. Eur J Nucl Med Mol Imaging. 2019 Jul;46(7):1518-1523. doi: 10.1007/s00259-019-04295-7. Epub 2019 Mar 8.
Other Identifiers
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NCI-2013-00535
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB-25970
Identifier Type: OTHER
Identifier Source: secondary_id
VARIMG0002
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-25970
Identifier Type: -
Identifier Source: org_study_id
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