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Clinical study of 99mTc-HPArk2 SPECT/CT for HER2 positive breast cancer

Clinical study of 99mTc-HPArk2 SPECT/CT for HER2 positive breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053412
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distant metastasis of breast cancer

Interventions

case series:Nil

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, and the pathological diagnosis can be obtained by operation or biopsy; 2. Clinical diagnosis or diagnosis of breast cancer; 3. Biopsy has confirmed metastasis of distant organs and tissues. It is proposed or confirmed to be HER2 receptor positive through IHC analysis, and Herceptin treatment is decided; 4. Informed consent in writing signed by the subject or his legal guardian and caregiver; 5. If necessary, the subject can be accompanied by nursing staff; 6. Before any evaluation, the subject or his legal representative understands and signs the written informed consent; 7. Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovariectomy or tubal ligation) or menopause for more than one year; If you still have the ability to conceive, you must take isolated contraceptive measures at the stage of this study; 8. Willing and able to cooperate with all projects of this study.

Exclusion criteria

Exclusion criteria: 1. Suffering from gastrointestinal, cardiovascular, renal, blood system, endocrine, respiratory system, immunodeficiency or other serious diseases; 2. In the past year, due to other clinical medical or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50 mSv; 3. History of drug or alcohol abuse; 4. Pregnant or lactating women. 5. Poor venous conditions, unable to tolerate repeated venipuncture; 6. Received (unclear effect or safety) experimental drug or device treatment within 1 month; 7. May be allergic to the components of 99mTc-HPArk2 injection; 8. Have any conditions that the host of this study believes that any link related to this experiment may cause harm or have potential harm.

Design outcomes

Primary

MeasureTime frame
Correlation between 99mTc hpark2 uptake and Herceptin efficacy;

Countries

China

Contacts

Public ContactSong Erwei

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

songew@mail.sysu.edu.cn+86 20 81332507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026