[18]F-Fluciclatide for Kidney Cancer Imaging Studies and Treatment

• Status: Withdrawn
• Trial end date: 2014-04-23
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• The experimental contrast agent [18]F-Fluciclatide is being tested for cancer treatment imaging studies. It is designed to show tumors in which new blood vessels are growing. Imaging studies with [18]F-Fluciclatide may help predict how well a tumor will respond to therapy that will prevent the growth of new blood vessels. Researchers will test [18]F-Fluciclatide before beginning treatment and after the first treatment cycle. Participants may also have a third scan with [18]F-Fluciclatide between 2 and 7 days after starting treatment to look for changes in blood vessel growth early after starting therapy.

Objectives:

• To test the safety and effectiveness of [18]F-Fluciclatide in predicting cancer treatment outcomes.

Eligibility:

• Individuals at least 18 years of age who will have kidney cancer treatment to stop tumor blood vessel growth.

Design:

• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor imaging studies and biopsies will be performed before starting the study.

• Participants will have two positron emission tomography (PET) and computed tomography (CT) scans. [18]F-Fluciclatide will be used for each scan. One scan will happen before the start of cancer treatment, and the second will happen after the first treatment cycle.

• Participants may also have an optional third PET/CT scan with [18]F-Fluciclatide. This scan will take place 2 to 7 days after beginning therapy.

• Depending on the location of the tumor, some participants may have an optional magnetic resonance imaging scan to look for changes in tumor blood flow and size. These scans will be done within 3 weeks of each [18]F-Fluciclatide PET/CT scan.

• The scans will be monitored with regular blood tests and vital signs.

• Participants will be followed for up to 1 year after the study to look for overall disease response to therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

• INCLUSION CRITERIA:

• Adult subjects (greater than or equal to18 years old), with documented renal malignancy or metastatic renal cancer, with at least one tumor greater than or equal to1 cm in diameter (not within the liver), who are scheduled for treatment using an anti-angiogenic therapy agent

• Platelet count of >100,000 times 10(6)/L, hemoglobin value of >9 g/dL, PT and an aPTT < 2 times normal limits.

• Clinically acceptable medical history, physical examination and vital signs findings during the screening period (from <4 weeks before administration of [18F] Fluciclatide); i.e. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.

• The subject has had no open surgical wounds in close proximity to the target lesion(s) within 10 days prior to study entry.

• The subject has not had a needle/core biopsy of the target lesion within 10 days of PET/CT imaging.

• The subject has not had radiation therapy to the region of the target lesion.

EXCLUSION CRITERIA:

• The subject is pregnant or nursing.

• The subject is being treated with doses of heparin or warfarin resulting in elevation of PT or aPTT >2 times normal.

• The subject has received any anti-angiogenic agent (e.g. bevacizumab, sorafenib, sunitinib) within 60 days prior to pre-treatment (baseline) [18F] Fluciclatide PE imaging. This stipulation does not apply after the baseline [18F] Fluciclatide PET imaging.

• The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. severe claustrophobia unrelieved by oral anxiolytics).

• The subject is unable to lie still for 75 minutes.

2.1.2.6 The subject is known to have a history of hyper- or hypo-coagulation syndromes resulting in prolongation of bleeding parameters. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor-V Leiden, and Bernard-Soulier syndrome.

• The subject has undergone a surgical procedure to the target lesion within 28 days prior to baseline [18F] Fluciclatide administration OR is scheduled to undergo a surgical procedure between the baseline and post 1-cycle [18F] Fluciclatide PET/CT.

• The subject has only bone metastasis

ADDITIONAL EXCLUSION CRITERIA FOR SUBJECTS UNDERGOING OPTIONAL MR:

• Serum creatinine within 2 weeks prior to MRI greater than or equal to1.8mg/dl OR estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m(2).

• The subject has known allergy to gadolinium

2.1.3.3 The subject has contraindications to MRI

• Subjects must weigh <136 kg (weight limit for scanner table).

• Subjects cannot have pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.