Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 1:47 PM
Study NCT ID:
NCT05001204
Status:
UNKNOWN
Last Update Posted:
2021-08-11
First Post:
2021-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
Status:
UNKNOWN
Status Verified Date:
2021-08
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:
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in Gastrointestinal stromal tumor（GIST）patients. A single dose of 55.5 to 148 MBq(1.5-4 mCi) of 68Ga-NOTA-RM26 will be injected intravenously. Patients underwent whole-body PET/CT scans at 30-90 minutes after intravenous injection.
Detailed Description:
Rm26 is a bioactive polypeptide containing 9 amino acid residues, which can specifically bind to gastrin releasing peptide receptor (GRPR, BB2 receptor). Previous studies have confirmed that there are a large number of GRPR receptors in human common types of tumors, such as lung cancer, breast cancer, prostate cancer, head and neck squamous cell carcinoma, glioma and gastrointestinal tumors. Therefore, the use of various radionuclide labeled gastrin releasing peptide receptor analogues RM26 for tumor targeted imaging and treatment greatly improves the early detection rate of tumor, and has important clinical significance and value in tumor staging, prognosis evaluation and curative effect evaluation.This prospective pilot study investigated the use of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR), for evaluating breast cancer using positron-emission tomography/computed tomography (PET/CT).
Study Oversight
Has Oversight DMC:
True
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?: