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Trial Title:
Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
NCT ID:
NCT05982626
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Her2-positive
Metastatic breast cancer
Positron-Emission Tomography
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
68Ga/131I-SGMIB-ZT-199
Description:
68Ga-SGMIB-ZT-199: PET imaging; 131I-SGMIB-ZT-199: SPECT imaging.
Arm group label:
68Ga/131I-SGMIB-ZT-199
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-ZT-199.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Breast cancer patients.
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:
- Subjects meeting any of the following criteria will be excluded from the study:
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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Huashan Hospital
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Yihui Guan
Phone:
+8613764308300
Email:
guanyihui@hotmail.com
Start date:
May 15, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982626
