Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer

April 19, 2022 updated by: Xichun Hu, Fudan University

A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Cancer Center Institutional Review Board
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

50 metastatic breast cancer patients

Description

Inclusion Criteria:

  1. Subjects voluntarily joined the study, signed informed consent, and had good compliance.
  2. Female patients aged over 18 years (including cutoff value).
  3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  4. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metastatic breast cancer patients
50 metastatic breast cancer patients
Procedure: biopsy or surgical pathology in metastases
biopsy or surgical pathology in extrahepatic/liver/brain metastases
Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES
68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify the subtype value of dual-PET in extrahepatic metastases
Time Frame: 2 year
Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify the HER2-PET value in liver metastasis
Time Frame: 2 year
Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in liver metastasis.
2 year
Verify the HER2-PET value in brain metastasis
Time Frame: 2 year
Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis.
2 year
Heterogeneity in metastatic lesions
Time Frame: 2 year
Observe the heterogeneity of ER and HER2 expression in metastatic lesions.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 14, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STANDPOINT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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