68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients | NCT02747290

Studies
68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients

NCT02747290

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Apr 21, 2016Estimated

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Prostate Cancer

Interventions

68Ga-NOTA-BBN-RGD

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ZIAEB000073	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Jul 2017Estimated

Completion Date

Not provided

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Name	Class
National Institute for Biomedical Imaging and Bioengineering (NIBIB)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description

Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis prostate cancer.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
68Ga-NOTA-BBN-RGD PET/CT	Experimental	The patients were injected with 111-148 MBq of 68Ga-NOTA-BBN-RGD in one dose intravenously and underwent PET/CT scan 15-30 min later.	Drug: 68Ga-NOTA-BBN-RGD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-NOTA-BBN-RGD	Drug	68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans	68Ga-NOTA-BBN-RGD PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in prostate cancer will be measured.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.

Exclusion Criteria:

The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhaohui Zhu, MD.PhD.	Contact	+86 10 69154196		13611093752@163.com
Jingjing Zhang, MD.PhD.	Contact	+86 10 69155513		zhangjingjingtag@163.com

Overall Officials

Name	Affiliation	Role
Fang Li, MD.	Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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Browse Branches

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