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

This study has been terminated.
(Study was closed to accrual because imaging agent was no longer available.)
Sponsor:
Information provided by (Responsible Party):
Adam Metwalli, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01712685
First received: October 20, 2012
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention Phase
Carcinoma, Renal Cell
Kidney Neoplasms
Drug: 18F-VM4-037
Procedure: PET/CT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET Imaging Of Renal Cell Carcinoma With 18F-VM4-037: A Phase II Pilot Study For Detection Of Disease And Correlation With VHL Mutation Status

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs) [ Time Frame: 58 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 58 days ] [ Designated as safety issue: Yes ]
    Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.


Enrollment: 12
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Cell Carcinoma Drug: 18F-VM4-037
Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans.
Procedure: PET/CT
N/A
Other Names:
  • Positron emission tomography
  • Computed tomography

Detailed Description:

BACKGROUND:

  • Carbonic Anhydrase IX (CA IX) is a hypoxia-inducible enzyme regulated by the Von Hippel Lindau (VHL) protein that is commonly overexpressed in certain malignancies including renal cell carcinoma (RCC) and may have prognostic significance.
  • The VHL gene is commonly mutated or inactivated in RCC tumors and VHL activity regulated the expression and activity of not only CAIX but also CAXII as well as other genes critical for tumor angiogenesis such as vascular endothelial growth factor (VEGF), glucose transporter 1 (GLUT1), glucose transporter 3 (GLUT 3) and platelet derived growth factor (PDGF).
  • 18F-VM4-037 is an imaging drug product formulation which binds to the active site ligand of CA-IX and also binds to CAXII. We propose to evaluate 18F-VM4-037 as a positron emission imaging (PET) radiopharmaceutical for the in vivo detection of CA-IX and CAXII in renal tumors.

STUDY OBJECTIVES

PRIMARY OBJECTIVE:

  • To evaluate the biodistribution of 18F-VM4-037 within tumor and non-tumor tissues.
  • To assess safety of 18F-VM4-037 in patients with primary or metastatic RCC.

ELIGIBILITY:

  • Subject is greater than or equal to 18 years old, Eastern Cooperative Oncology Group (ECOG) 0-2.
  • Subject must have confirmed primary RCC (greater than or equal to 2.5cm) in diameter on conventional imaging modality or extrarenal/extrahepatic RCC lesion (greater than or equal to 1cm).

DESIGN:

- Twenty subjects with primary RCC greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic lesion suspicious for metastatic RCC (greater than or equal to 1cm in diameter) scheduled for clinically indicated surgery or biopsy will undergo dynamic 18F-VM4-037 PET/CT imaging. Results will be compared with pathology.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712685

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Adam R Metwalli, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: Adam Metwalli, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01712685     History of Changes
Other Study ID Numbers: 130018, 13-C-0018
Study First Received: October 20, 2012
Results First Received: July 31, 2014
Last Updated: September 16, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
Kidney Neoplasm
RCC
Biodistribution of 18F-VM4-037
CAIX Staining
Tumor Angiogenesis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms
Adenocarcinoma
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014