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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

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Renal Cell, Kidney Neoplasms

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Trial Information

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


- 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.



- 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.


- 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).


- 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.

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.


- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Quantitative measurements of the level of uptake of 18F-VM4-037 in tumor and non tumor tissues, calculated as SUVs

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Adam R Metwalli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

October 2012

Completion Date:

November 2014

Related Keywords:

  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Kidney Neoplasm
  • RCC
  • Biodistribution of 18F-VM4-037
  • CAIX Staining
  • Tumor Angiogenesis
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892