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

Inclusion 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.