68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-RM26
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Stromal Tumors focused on measuring PET/CT, RM26, GRPR, gastrin-releasing peptide receptor
Eligibility Criteria
Inclusion Criteria:
- Patients in suspicion of gastrointestinal stromal tumors by CT or ultrasonography,and being able to provide basic information and sign the written informed consent form.
Exclusion Criteria:
- The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding.
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-NOTA-RM26 PET/CT
Arm Description
Patients underwent whole-body PET/CT scans at 30-90 minutes after intravenous injection of 55.5-148 MBq (1.5-4 mCi) of 68Ga-NOTA-RM26.
Outcomes
Primary Outcome Measures
Standardized uptake value of 68Ga-NOTA-RM26 in gastrointestinal stromal tumor
The quantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (suv) of the tracer in Gastrointestinal stromal tumors will be measured.
Secondary Outcome Measures
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Full Information
NCT ID
NCT05001204
First Posted
August 6, 2021
Last Updated
August 6, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05001204
Brief Title
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
Official Title
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
PET/CT, RM26, GRPR, gastrin-releasing peptide receptor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-NOTA-RM26 PET/CT
Arm Type
Experimental
Arm Description
Patients underwent whole-body PET/CT scans at 30-90 minutes after intravenous injection of 55.5-148 MBq (1.5-4 mCi) of 68Ga-NOTA-RM26.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-RM26
Intervention Description
68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga-NOTA-RM26 in gastrointestinal stromal tumor
Description
The quantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (suv) of the tracer in Gastrointestinal stromal tumors will be measured.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients in suspicion of gastrointestinal stromal tumors by CT or ultrasonography,and being able to provide basic information and sign the written informed consent form.
Exclusion Criteria:
The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongxi Wang
Phone
+8619800370331
Email
pumch_jacobwong@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD
Phone
13611093752
Email
13611093752@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongxi Wang
Phone
+8619800370331
Email
pumch_jacobwong@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
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