search
Back to results

Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

Primary Purpose

HER2-positive Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga/131I-SGMIB-5F7
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HER2-positive Breast Cancer focused on measuring Her2-positive, Metastatic breast cancer, Positron-Emission Tomography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Breast cancer patients. Women aged between 18 and 75 years old. Patients with breast cancer confirmed by histological examination or imaging. HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)). Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities. Patients of childbearing age can cooperate with contraception. Willing and able to cooperate with all items of this study. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: Severe hepatic or renal insufficiency; Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study. Participation in this study is considered unsuitable by other investigators. Pregnant women and other groups unsuitable to receive radiation. Alcohol allergy, etc.

Sites / Locations

  • Huashan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga/131I-SGMIB-5F7

Arm Description

68Ga/131I-SGMIB-5F7, single dose

Outcomes

Primary Outcome Measures

Dosimetry
To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-5F7, assessed by PET/SPECT imaging.

Secondary Outcome Measures

Safety Assessment
Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0

Full Information

First Posted
July 7, 2023
Last Updated
August 1, 2023
Sponsor
Huashan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05982626
Brief Title
Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
Official Title
Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of [131I]/[68Ga]SGMIB-5F7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
Her2-positive, Metastatic breast cancer, Positron-Emission Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga/131I-SGMIB-5F7
Arm Type
Experimental
Arm Description
68Ga/131I-SGMIB-5F7, single dose
Intervention Type
Radiation
Intervention Name(s)
68Ga/131I-SGMIB-5F7
Intervention Description
68Ga-SGMIB-5F7: PET imaging; 131I-SGMIB-5F7: SPECT imaging.
Primary Outcome Measure Information:
Title
Dosimetry
Description
To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-5F7, assessed by PET/SPECT imaging.
Time Frame
about 24hours from time of injection
Secondary Outcome Measure Information:
Title
Safety Assessment
Description
Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0
Time Frame
From administration of [131I]SGMIB-5F7 until 1 week after injection

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Breast cancer patients. Women aged between 18 and 75 years old. Patients with breast cancer confirmed by histological examination or imaging. HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)). Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities. Patients of childbearing age can cooperate with contraception. Willing and able to cooperate with all items of this study. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: Severe hepatic or renal insufficiency; Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study. Participation in this study is considered unsuitable by other investigators. Pregnant women and other groups unsuitable to receive radiation. Alcohol allergy, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihui Guan, MD
Phone
13764308300
Ext
+86
Email
guanyihui@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Xie, PhD
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

We'll reach out to this number within 24 hrs