Breast Cancer Clinical Trial
Official title:
Whether 18F-ALF-NOTA-PRGD2 PET/CT Scan Can Predict the Efficacy and Adverse Events of Apatinib in Patients With Malignancies.
Verified date | February 2018 |
Source | Shandong Cancer Hospital and Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 PET/CT scan can
predict the efficacy and adverse events of apatinib in patients with malignancies.
Integrin αvβ3 has been shown to play an important role in angiogenesis and up-regulated
obviously in various types of tumor cells and activated endothelial cells. The
arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high
affinity and specificity. The 18F-ALF-NOTA-PRGD2 will highly combine with αvβ3, and thus will
monitor the antiangiogenic status.In the current study, investigators propose to evaluate the
feasibility of 18F-RGD PET/CT in monitoring efficacy and adverse events of apatinib in
malignancies.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 28, 2018 |
Est. primary completion date | January 28, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of malignancies - Scheduled for second- or third-line apatinib therapy - Karnofsky performance status (KPS) =70 - Measurable primary tumors according to Response Evaluation Criteria in Solid Tumors (RECIST) Exclusion Criteria: - Active infection, myocardial infarction within 6 months, symptoms of heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy - The claustrophobic patients and patients with implanted metal objects - The pregnancy - Inability to complete the required examinations |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shandong Cancer Hospital and Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response defined by RECIST criteria | Tumor response will be evaluated as complete response or partial response or stable disease or PD according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | At 1 month of the study | |
Secondary | Days from the start of therapy to disease progression or death due to any cause | Progression free survival (evaluated by RECIST criteria), defined as the interval from start of therapy to investigator-assessed progression or death due to any cause, whichever occurs first or lost of follow-up. | At 6 months of the study | |
Secondary | Days from the start of therapy to death due to any cause | Overall survival is the time interval from the start of therapy to death due to any reason or lost of follow-up. | Up to 12 months | |
Secondary | Treatment-Related Adverse Events as Assessed by CTCAE | Common Terminology Criteria for Adverse Events (CTCAE) | Through study completion, an average of 6 months |
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