The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384511
• Other study ID #: CRTOG1701
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2017
• Last updated: February 19, 2018
• Start date: September 30, 2016
• Est. completion date: January 28, 2018

Study information

• Verified date: February 2018
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is an open-label, single arm study to explore whether 18F-ALF-NOTA-PRGD2 positron emission tomography/computed tomography (18F-RGD PET/CT) scan can predict the efficacy and adverse events of apatinib in patients with malignancies.

Angiogenesis, the formation of new blood vessels, is the process of generating neovascularization from preexisting vessels. It can promote tumor growth and metastasis by providing nutrients and oxygen. 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. Since the arginine-glycine-aspartic acid (RGD) tripeptide sequence can bind to integrin αvβ3 with high affinity and specificity, RGD PET/CT may be helpful to evaluate the biological and metabolic activity status during angiogenesis. However, 18F-ALF-NOTA-PRGD2 PET/CT as response biomarker for antiangiogenic therapy has not been fully proved and is still without universal understanding according to current publications. Apatinib (YN968D1) is the first orally antiangiogenic drug targeting VEGFR-2 tyrosine kinase.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. Patients confirmed malignancies histopathologically will be prospectively enrolled in the study. All patients provided written informed consent prior to enrollment. Patients will receive apatinib therapy, and undergo 18F-RGD PET/CT scans berore and after first cycle of therapy.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Cervical Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Malignancies
• Neoplasms
• Non-small Cell Lung Cancer
• Ovarian Neoplasms
• Ovary Cancer
• Stomach Cancer
• Stomach Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• Apatinib
Patients will accept apatinib therapy and undergo baseline 18F-ALF-NOTA-PRGD2 PET/CT scans of the whole body after having met all eligibility criterias.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

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