Back to results[18F]Fluciclatide PET Imaging of Pazopanib Response
Primary Purpose
Kidney Neoplasm
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
18F-Fluciclatide
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Neoplasm
Eligibility 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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug; 18F-Fluciclatide
Arm Description
18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
Progression free survival more than 6 month
Progression free survival defined as time from PET scan to the date of death, recurrence or progression
Full Information
NCT ID
NCT01961583
First Posted
October 7, 2013
Last Updated
February 27, 2016
Sponsor
Asan Medical Center
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01961583
Brief Title
[18F]Fluciclatide PET Imaging of Pazopanib Response
Official Title
Evaluation of [18F]FluciclatidePositron Emission Tomography For the Prediction of Response to Pazopanib In Patients With Metastatic Renal Cell Carcinoma: An Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Termination of [18F]Fluciclatide production
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Subjects will receive treatment with pazopanib at a dose of 800 mg orally once daily. [18F]Fluciclatide imagings will be taken 2 times; 1) before systemic therapy (at baseline), 2) at one week after starting of Pazopanib. However, If the target lesion on the baseline PET cannot be discriminated compared to the background activity, the 2nd PET will not be done. Response evaluation by CT will be performed at baseline, at 6 week, at 12 week and every 8 weeks thereafter until the end of treatment. RECIST1.1 criteria for response will be applied. Patient will be treated with Pazopanib until there is disease progression, unacceptable toxicity or withdrawal of patient consent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug; 18F-Fluciclatide
Arm Type
Experimental
Arm Description
18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration
Intervention Type
Drug
Intervention Name(s)
18F-Fluciclatide
Other Intervention Name(s)
AH111585
Intervention Description
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
Primary Outcome Measure Information:
Title
Baseline 18F-Fluciclatide PET SUV
Description
The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy
Time Frame
Prior to starting Pazopanib treatment
Secondary Outcome Measure Information:
Title
The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
Time Frame
7±1 days after Pazopanib treatment
Title
Progression free survival more than 6 month
Description
Progression free survival defined as time from PET scan to the date of death, recurrence or progression
Time Frame
More than 6 month after 1st PET scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Sook Ryu, MD. PhD.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://www.nlm.nih.gov/medlineplus
Description
Cancer, Nuclear Scans
URL
http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
Description
Pazopanib
Learn more about this trial
[18F]Fluciclatide PET Imaging of Pazopanib Response
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