Clinical trial · Interventional
Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
NCT05982626CI-TRIAL-00076409unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga/131I-SGMIB-ZT-199 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga/131I-SGMIB-ZT-199
- description
- 68Ga/131I-SGMIB-ZT-199, single dose
- interventionNames
- Radiation: 68Ga/131I-SGMIB-ZT-199
Primary outcomes (1)
- measure
- Dosimetry
- timeFrame
- about 24hours from time of injection
- description
- To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from \[131I\]SGMIB-ZT-199, assessed by PET/SPECT imaging.
Secondary outcomes (1)
- measure
- Safety Assessment
- timeFrame
- From administration of [131I]SGMIB-ZT-199 until 1 week after injection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.