HER2 Positive or Suspicious Positive Tumors Clinical Trial
Official title:
Research for the Molecular Imaging of the HER2 Targeting Tracer
Verified date | November 2023 |
Source | Peking University Cancer Hospital & Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To use the molecular PET radionuclide (Ga-68 or F-18) labelled HER2 Affibody to detect the expression of HER2 in the primary and metastatic lesions in patients with HER2 positive or suspicious positive tumors; to detect the expression heterogeneity of HER2 in the lesions and inter-lesions; to observe the change of HER2 expression in the course of treatment. To provide an approach for screening patients high expression of HER2, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 30, 2026 |
Est. primary completion date | August 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Aged > 18 years old; ECOG 0 or 1; 2. Patients with HER2 positive or suspicious positive tumors; 3. Has at least one measurable target lesion according to CT or MRI; 4. Life expectancy = 12 weeks. Exclusion Criteria: 1. Significant hepatic or renal dysfunction; 2. Is pregnant or ready to pregnant; 3. Cannot keep their states for half an hour; 4. Refused to join the clinical research; 5. Suffering from claustrophobia or other mental disorders; 6. Any other situation that researchers considered it unsuitable to participate in the trial. |
Country | Name | City | State |
---|---|---|---|
China | Hua Zhu | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Cancer Hospital & Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUV | The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT | 3 years |