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

Study Overview
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Brief Summary
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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.

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

Conditions
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HER2-positive Breast Cancer

Intervention / Treatment
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* Radiation: 68Ga/131I-SGMIB-5F7


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga/131I-SGMIB-5F7<br>68Ga/131I-SGMIB-5F7, single dose | Radiation: 68Ga/131I-SGMIB-5F7<br>* 68Ga-SGMIB-5F7: PET imaging; 131I-SGMIB-5F7: SPECT imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry | To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-5F7, assessed by PET/SPECT imaging. | about 24hours from time of injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0 | From administration of [131I]SGMIB-5F7 until 1 week after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Her2-positive, Metastatic breast cancer, Positron-Emission Tomography