99mTc Labelled Affibody SPECT/CT Imaging for Breast Cance... | NCT03546478

Studies
99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

NCT03546478

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Jun 6, 2018Actual

Enrollment

32Actual

Phase

Early Phase 1

Conditions

Breast Cancer

Interventions

99mTc-ABH2

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

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2015Actual

Primary Completion Date

May 24, 2017Actual

Completion Date

May 18, 2018Actual

First Submitted Date

May 23, 2018

First Submission Date that Met QC Criteria

Jun 4, 2018

First Posted Date

Jun 6, 2018Actual

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

Jun 4, 2018

Last Update Posted Date

Jun 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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 single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed Description

99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-ABH2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-ABH2 SPECT/CT in stratifying breast 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

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
99mTc-ABH2 SPECT/CT	Experimental	The patients were injected with 370±54 MBq of 99mTc-ABH2 in one dose intravenously and underwent SPECT/CT scan 90-270 min later.	Biological: 99mTc-ABH2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
99mTc-ABH2	Biological	99mTc-ABH2 were injected into the patients before the SPECT/CT scans	99mTc-ABH2 SPECT/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
T/B	Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer	1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female

Exclusion Criteria:

Pregnancy Breastfeeding Renal function: serum creatinine > 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

29 Years

Maximum Age

76 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided