Imaging Studies of Kidney Cancer Using 18F-VM4-037

NCT01712685 | Terminated Phase 2 Results

• 2 other identifiers: 13001813-C-0018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. Researchers want to see how well it works for scans for people who have kidney cancer. Objectives: \- To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer. Eligibility: \- Adults at least 18 years of age with kidney cancer that will be treated with surgery. Design:

• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
• Participants will have two positron emission tomography (PET) scans of their kidneys. They will have the scans before and after receiving an injection of 18F-VM4-037. The scans will take about 2 hours to complete.
• About 3 weeks after the PET scans, participants will provide tumor tissue samples from their kidneys.
• This is a scanning study only. Treatment will not be provided as part of this study.

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Keywords

Kidney Neoplasm; RCC; Biodistribution of 18F-VM4-037; CAIX Staining; Tumor Angiogenesis

Outcome Measures

Primary Outcomes (1)

• Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)

  The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue.

  58 days

Secondary Outcomes (8)

• Number of Participants With Adverse Events

  58 days

• Mean Standard Uptake Value (SUV) for All Target Lesions

  Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.

• Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)

  Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.

• Mean Standard Uptake Value (SUV) for Normal Kidney

  Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.

• Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene

  21 days prior to enrollment until closure of the study, approximately 14 months.

Study Arms (1)

Renal Cell Carcinoma

EXPERIMENTAL

Drug: 18F-VM4-037; Procedure: PET/CT

Interventions

18F-VM4-037 DRUG

Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans.

Renal Cell Carcinoma

PET/CT PROCEDURE

Also known as: Positron emission tomography, Computed tomography

Renal Cell Carcinoma

Eligibility Criteria

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

You may qualify if:

• Subject is greater than or equal to18 years old.
• Subject must be scheduled to undergo surgery or biopsy for primary renal cell carcinoma (RCC) greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic metastatic RCC lesion (greater than or equal to1cm in diameter) at the National Institutes of Health (NIH) Clinical Center based on imaging within 3 weeks.
• Chemistry parameters: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2 times of the upper limits of normal; total bilirubin, of \< 2 times the upper limits of normal or \< 3.0 mg/dl in patients with Gilberts syndrome.
• Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
• Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.
• The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from within 21 days before administration of 18F-VM4-037). Components of an acceptable medical history include no active infection at the time of enrollment or within 7 days of enrollment, no prior therapy that results in immunocompromise or impaired renal function (serum creatinine within 2 weeks prior to positron emission tomography (PET) imaging less than or equal to1.8 mg/dl and epidermal growth factor receptor (eGFR) must be \> 30 ml/min/1.73m\^2) or findings indicating an inability to tolerate the requirements for the scan. Previous exposure to immunocompromising therapy does not exclude the patient; patients must have an absolute neutrophil count \> 1.5/microL within 2 weeks of PET imaging.
• If female, must have a negative serum human chorionic gonadotropin (HCG) within 24 hours prior to 18F-VM4-037 injection OR be post menopausal for \> 2 years OR be surgically sterile.

You may not qualify if:

• Subjects for whom participating would significantly delay the scheduled standard of care therapy.
• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
• Subjects with severe claustrophobia unresponsive to oral anxiolytics.
• Other medical conditions deemed by the principle investigator (or associates) or sponsor to make the subject ineligible for protocol procedures.
• Female subject is pregnant or nursing
• The site of the target lesion must not have been part of a radiation portal within 6 months of enrollment.
• Subjects having received another investigational agent within 1 month before administration of 18F-VM4-037.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.

  PMID: 14974761 BACKGROUND

• Latif F, Tory K, Gnarra J, Yao M, Duh FM, Orcutt ML, Stackhouse T, Kuzmin I, Modi W, Geil L, et al. Identification of the von Hippel-Lindau disease tumor suppressor gene. Science. 1993 May 28;260(5112):1317-20. doi: 10.1126/science.8493574.

  PMID: 8493574 BACKGROUND

• Seizinger BR, Rouleau GA, Ozelius LJ, Lane AH, Farmer GE, Lamiell JM, Haines J, Yuen JW, Collins D, Majoor-Krakauer D, et al. Von Hippel-Lindau disease maps to the region of chromosome 3 associated with renal cell carcinoma. Nature. 1988 Mar 17;332(6161):268-9. doi: 10.1038/332268a0.

  PMID: 2894613 BACKGROUND

• Turkbey B, Lindenberg ML, Adler S, Kurdziel KA, McKinney YL, Weaver J, Vocke CD, Anver M, Bratslavsky G, Eclarinal P, Kwarteng G, Lin FI, Yaqub-Ogun N, Merino MJ, Linehan WM, Choyke PL, Metwalli AR. PET/CT imaging of renal cell carcinoma with (18)F-VM4-037: a phase II pilot study. Abdom Radiol (NY). 2016 Jan;41(1):109-18. doi: 10.1007/s00261-015-0599-1.

  PMID: 26830617 RESULT

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

3-(4-(2-fluoroethoxy)phenyl)-2-(3-methyl-2-(4-((2-sulfamoylbenzo(d)thiazol-6-yloxy)methyl)-1H-1,2,3-triazol-1-yl)butanamido)propanoic acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Study was closed to accrual because imaging agent was no longer available.

Results Point of Contact

• Title: Dr. Adam Metwalli
• Organization: National Cancer Institute

metwallia@mail.nih.gov

301-435-6237

Study Officials

• Adam R Metwalli, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 11, 2017
• Results First Posted: September 19, 2014

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)