Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147362
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-11-17
Brief Title:
68Ga-NOTA-PEG2-RM26 PETCT First in Man Study
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
68Ga-NOTA-PEG2-RM26 PETCT Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor GRPR Overexpression
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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 tomographycomputed tomography PETCT study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PEG2-RM26 in prostate cancer patients A single dose of 2 MBqkg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq per examination will be given intravenously Visual and semiquantitative method will be used to assess PETCT images
Detailed Description:
The gastrin-releasing peptide receptor GRPR also known as bombesin receptor subtype II BB2 is a member of the G protein-coupled receptor family of bombesin receptors GRPR is over-expressed in various types of human tumors RM26 a GRPR antagonist with high affinity was discovered by peptide backbone modification of bombesin analogues
To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga
An open-label whole-body PET CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer
To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga
An open-label whole-body PET CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer
Study Oversight
Has Oversight DMC:
None
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?:
None