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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546478
• Other study ID #: CaiJ
• Status: Completed
• Phase: Early Phase 1
• Start date: June 24, 2015
• Est. completion date: May 18, 2018

Study information

• Verified date: May 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 18, 2018
• Est. primary completion date: May 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 29 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• 99mTc-ABH2
99mTc-ABH2 were injected into the patients before the SPECT/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T/B	Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer	1 year
Secondary	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients will be followed and assessed	1 week