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

NCT01806675 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: IRB-25970NCI-2013-00535VARIMG0002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Maximum Standard Uptake Values (SUVmax)

  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.

  At baseline and 6 weeks

Secondary Outcomes (4)

• Response Assessment by RANO Criteria

  At baseline and 6 weeks

• Change in Tumor Size

  9 to 12 weeks

• Tumor Response Rate by EORTC Criteria

  At baseline and 6 weeks

• Progression-free Survival (PFS)

  1 year

Study Arms (3)

Glioblastoma Multiforme (GBM)

EXPERIMENTAL

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)

Drug: 18F-fludeoxyglucose (18F-FDG); Drug: 18F-FPPRGD2

Gynecological Cancers

EXPERIMENTAL

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)

Drug: 18F-fludeoxyglucose (18F-FDG); Drug: 18F-FPPRGD2

Renal Cell Cancer (RCC)

EXPERIMENTAL

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)

Drug: 18F-fludeoxyglucose (18F-FDG); Drug: 18F-FPPRGD2

Interventions

18F-fludeoxyglucose (18F-FDG) DRUG

18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan

Also known as: Fludeoxyglucose F-18, 18-FDG, FDG

Glioblastoma Multiforme (GBM); Gynecological Cancers; Renal Cell Cancer (RCC)

18F-FPPRGD2 DRUG

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.

Also known as: (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

Glioblastoma Multiforme (GBM); Gynecological Cancers; Renal Cell Cancer (RCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant or nursing
• Contraindication to MRI
• History of renal insufficiency (only for MRI contrast administration)

Sponsors & Collaborators

• Sanjiv Sam Gambhir: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (4)

• 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.

  PMID: 26062933 RESULT

• 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.

  PMID: 25965900 RESULT

• 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.

  PMID: 26611425 RESULT

• 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.

  PMID: 30850872 RESULT

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Breast Neoplasms, Male; Brain Neoplasms; Colonic Neoplasms; Esthesioneuroblastoma, Olfactory; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Carcinoma, Non-Small-Cell Lung; Oropharyngeal Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms; Carcinoma, Renal Cell; Salivary Gland Neoplasms; Breast Neoplasms; Tongue Neoplasms

Interventions

Fluorodeoxyglucose F18; FPP(RGD)2

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neuroblastoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Olfactory Nerve Diseases; Cranial Nerve Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Mouth Diseases; Nasopharyngeal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Thoracic Neoplasms; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Salivary Gland Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Sanjiv Sam Gambhir, Professor for Clinical Investigation in Cancer Research and Professor
• Organization: Stanford University

sgambhir@stanford.edu

650-725-6175

Study Officials

• Sanjiv Gambhir, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All human subject participants were to be evaluated with both 18F-FPPRGD2 PET/CT and 18-FDG PET/CT imaging scans.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 7, 2013
• Study Start: March 4, 2013
• Primary Completion: December 7, 2016
• Study Completion: April 1, 2019
• Last Updated: October 3, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)