[18F]Fluciclatide PET Imaging of Pazopanib Response

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo. The PET tracer [18F]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and mature endothelial cells but are expressed at high levels on activated endothelial cells in the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib acts mainly on active angiogenetic tumors, the quantitative uptake of [18F]Fluciclatide can be used to predict the effect of this antiangiogenic drug. The investigators expected the baseline tumor uptake in [18F]Fluciclatide to be able to predict treatment response, and planned a study of [18F]FluciclatidePET for patients with metastatic RCC who received pazopanib systemic therapy.

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: GE Healthcare

Criteria

Inclusion Criteria:

• Histologically confirmed renal cell carcinoma, stage IV patient.

• The tumor mass ≥1.5cm in diameter that is planned to receive Pazopanib as systemic antiangiogenic therapy.

• Pretreatment CT with or without contrast within 4 weeks prior to the first 18F-Fluciclatide PET scan.

• Evidence of unidimensionally measurable lesion(s) by RECIST criteria version 1.1.

• No prior systemic anti-angiogenic therapy for metastatic disease; prior antiangiogenic therapy used as an adjuvant therapy is allowed if it is completed 6 or more months before study enrollment.

• Male or female aged over 20 years

• Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Have a life expectancy of at least 3 months.

• Adequate medical condition in the judgment of the investigator

• Be willing and able to comply with the protocol for the duration of the study.

• Be willing and able to implement effective contraceptive practice

• Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

• Received another IMP within 30 days before the first administration of 18F-Fluciclatide injection.

• Inability to perform 18F-Fluciclatide PET imaging studies due to physical inability or claustrophobia.

• Intra-hepatic tumor only (without extra-hepatic tumor)

• Chemotherapy within 2weeks, or received radiotherapy to the region of the target lesion, surgery of target lesion within 2 weeks prior to the first 18F-Fluciclatide PET scan

• Pregnant, nursing women or patients with reproductive potential without contraception.

• Current treatment on another therapeutic clinical trial(except Pazopanib study)

• Any patients with known allergy to the GE health care product or any or its excipients should be excluded from the study

• Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.