Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 8:58 PM
Study NCT ID:
NCT04769050
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2021-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Phase II, Single-center, Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment
Detailed Description:
Participants participated in the screening period visit, and received HER2-PET and 18 F-FDG PET/CT examinations before receiving tumor treatment, after receiving 2 cycles of chemotherapy, and after disease progression. Patients of first-line received docetaxel combined with trastuzumab±pertuzumab regimen, and patients of second-line received T-DM1 monotherapy or capecitabine combined with pyrrotinib regimen.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: