[18F]Fluciclatide PET Imaging of Pazopanib Response

NCT01961583 | Terminated Phase 2

• 1 other identifier: 2013-0382
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Neoplasm

Outcome Measures

Primary Outcomes (1)

• Baseline 18F-Fluciclatide PET SUV

  The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy

  Prior to starting Pazopanib treatment

Secondary Outcomes (2)

• The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria

  7±1 days after Pazopanib treatment

• Progression free survival more than 6 month

  More than 6 month after 1st PET scan

Study Arms (1)

Drug; 18F-Fluciclatide

EXPERIMENTAL

18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration

Drug: 18F-Fluciclatide

Interventions

18F-Fluciclatide DRUG

Baseline 18F-Fluciclatide PET imaging will be obtained before starting of Pazopanib therapy(within 7 days). Subsequent 18F-Fluciclatide PET should be performed on 7 days after Pazopanib therapy

Also known as: AH111585

Drug; 18F-Fluciclatide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• GE Healthcare: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Related Links

• Cancer, Nuclear Scans
• Pazopanib

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

AH 111585

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jin-Sook Ryu, MD. PhD.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 11, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

KR (1)