NCT04758416

Brief Summary

Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

February 14, 2021

Last Update Submit

April 19, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Verify the subtype value of dual-PET in extrahepatic metastases

    Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.

    2 year

Secondary Outcomes (3)

  • Verify the HER2-PET value in liver metastasis

    2 year

  • Verify the HER2-PET value in brain metastasis

    2 year

  • Heterogeneity in metastatic lesions

    2 year

Study Arms (1)

Metastatic breast cancer patients

50 metastatic breast cancer patients

Procedure: biopsy or surgical pathology in metastasesDrug: 68Ga-HER2 affibody,18F-FDG, 18F-FES

Interventions

biopsy or surgical pathology in metastasesPROCEDURE

biopsy or surgical pathology in extrahepatic/liver/brain metastases

Metastatic breast cancer patients
68Ga-HER2 affibody,18F-FDG, 18F-FESDRUG

68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.

Metastatic breast cancer patients

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 metastatic breast cancer patients

You may qualify if:

  • Subjects voluntarily joined the study, signed informed consent, and had good compliance.
  • Female patients aged over 18 years (including cutoff value).
  • an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer.

You may not qualify if:

  • Pregnancy or lactation.
  • Alcohol allergy is not suitable for FES-PET/ C.
  • There are contraindications for patients who are expected to have metastasis puncture or surgery.
  • Mental disorders or other conditions affecting patient compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center Institutional Review Board

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy16-fluoroestradiol

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Xichun Hu, MD, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, MD, PhD

CONTACT

64175590huxicun@gmail.com

Jian Zhang, M.D.

CONTACT

64175590syner2000@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of medical oncology

Study Record Dates

First Submitted

February 14, 2021

First Posted

February 17, 2021

Study Start

December 31, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)