Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
NCT ID: NCT05982626
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2023-05-15
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga/131I-SGMIB-ZT-199
68Ga/131I-SGMIB-ZT-199, single dose
68Ga/131I-SGMIB-ZT-199
68Ga-SGMIB-ZT-199: PET imaging; 131I-SGMIB-ZT-199: SPECT imaging.
Interventions
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68Ga/131I-SGMIB-ZT-199
68Ga-SGMIB-ZT-199: PET imaging; 131I-SGMIB-ZT-199: SPECT imaging.
Eligibility Criteria
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Inclusion Criteria
1. Women aged between 18 and 75 years old.
2. Patients with breast cancer confirmed by histological examination or imaging.
3. 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+)).
4. Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
5. Patients of childbearing age can cooperate with contraception.
6. Willing and able to cooperate with all items of this study.
Exclusion Criteria
1. Severe hepatic or renal insufficiency;
2. 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.
3. Participation in this study is considered unsuitable by other investigators.
4. Pregnant women and other groups unsuitable to receive radiation.
5. Alcohol allergy, etc.
18 Years
75 Years
FEMALE
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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YiHui Guan
Professor
Principal Investigators
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Fang Xie, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Huashan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2023-545
Identifier Type: -
Identifier Source: org_study_id
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