Clinical trial NCT01806675: 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Official title: Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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 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)

Primary outcomes:
measure: Change From Baseline in Maximum Standard Uptake Values (SUVmax)
timeFrame: At baseline and 6 weeks
Secondary outcomes:
measure: Response Assessment by RANO Criteria
timeFrame: At baseline and 6 weeks
measure: Change in Tumor Size
timeFrame: 9 to 12 weeks
measure: Tumor Response Rate by EORTC Criteria
timeFrame: At baseline and 6 weeks
measure: Progression-free Survival (PFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sanjiv Gambhir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.