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

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ClinicalTrials.gov Identifier: NCT04758416
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease Intervention/treatment
Breast Cancer Procedure: biopsy or surgical pathology in metastases Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES

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)

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: 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)
Actual Study Start Date : December 31, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. Heterogeneity in metastatic lesions [ Time Frame: 2 year ]
    Observe the heterogeneity of ER and HER2 expression in metastatic lesions.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
50 metastatic breast cancer patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758416


Contacts
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Contact: Xichun Hu, MD, PhD 64175590 ext 5006 huxicun@gmail.com
Contact: Jian Zhang, M.D. 64175590 ext 85000 syner2000@163.com

Locations
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China, Shanghai
Shanghai Cancer Center Institutional Review Board Recruiting
Shanghai, Shanghai, China
Contact: Xichun Hu, MD, PhD    64175590 ext 5006    huxicun@gmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xichun Hu, MD, PhD Fudan University
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Responsible Party: Xichun Hu, Director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier: NCT04758416    
Other Study ID Numbers: STANDPOINT
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action