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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01712685
First received: October 20, 2012
Last updated: March 14, 2014
Last verified: March 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: Allocation: Non-Randomized
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:
  • Quantitative measurements of the level of uptake of 18F-VM4-037 in tumor and non tumor tissues, calculated as SUVs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evaluate each clinical laboratory result, vital sign results and ECG results [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Examine relationship b/t uptake of 18F-VM4-037 and CA-IX expression in RCC lesions detected by quantitative IHC. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the ability of imaging with 18F-VM4-037 to detect malignant tumors vs. results of histopathology [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: 18F-VM4-037
    N/A
    Procedure: PET/CT
    N/A
Detailed Description:

BACKGROUND:

  • Carbonic Anhydrase IX (CA IX) is a hypoxia-inducible enzyme regulated by the 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 VEGF, GLUT1, GLUT 3 and 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. Wepropose to evaluate 18F-VM4-037 as a 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, 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 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 NIH Clinical Center based on imaging within 3 weeks.
  • Chemistry parameters: AST and ALT less than or equal to2 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 Gilbert s 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 PET imaging less than or equal to1.8 mg/dl and 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 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
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: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01712685     History of Changes
Other Study ID Numbers: 130018, 13-C-0018
Study First Received: October 20, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 16, 2014