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Clinical Trial of 99mTc-3PRGD2 SPECT/CT in Image Diagnosis and Staging in Breast Cancer

Clinical Trial of 99mTc-3PRGD2 SPECT/CT in Image Diagnosis and Staging in Breast Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049897
Enrollment
Unknown
Registered
2021-08-10
Start date
2021-08-09
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Breast cancer

Interventions

Index test:99mTc-3PRGD2&#32

Sponsors

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

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, can obtain pathological diagnosis by surgery or biopsy; 2. Clinically diagnosed or diagnosed breast cancer; 3. Biopsy has confirmed metastasis to distant organs or tissues; 4. An informed consent form must be signed in writing by the subject or his legal guardian or caregiver; 5. If necessary, the subject can be accompanied by a nursing staff; 6. Before any evaluation, the subject or his legal representative understands and signs a written informed consent; 7. Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy or tubal ligation) or menopause for more than one year; if they still have the ability to conceive, they must take isolated contraception during this research stage measure; 8. Willing and able to cooperate with all projects of this research.

Exclusion criteria

Exclusion criteria: 1. Suffering from gastrointestinal, cardiovascular, renal, hematological, endocrine, respiratory, immune deficiency or other serious diseases; 2. Has been exposed to ionizing radiation outside the scope of this study in the past year due to other clinical medical or scientific needs, resulting in an annual radiation exposure of more than 50 mSv; 3. History of drug or alcohol abuse; 4. Pregnant or breastfeeding women; 5. Poor venous condition, unable to tolerate repeated venipuncture; 6. Treatment with an experimental drug or device (whose efficacy or safety is not clear) within 1 month; 7. May be allergic to 99mTC-3PRGD2 injection; 8. Any conditions that may cause or potentially cause harm in any link related to the test according to the research leader.

Design outcomes

Primary

MeasureTime frame
Accuracy;

Secondary

MeasureTime frame
Specificity;

Countries

China

Contacts

Public ContactSong Erwei

Sun Yat-Sen Memorial Hospital, 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