- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001204
68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor
August 6, 2021 updated by: Peking Union Medical College Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rongxi Wang
- Phone Number: +8619800370331
- Email: pumch_jacobwong@163.com
Study Contact Backup
- Name: Zhaohui Zhu, MD
- Phone Number: 13611093752
- Email: 13611093752@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
-
Contact:
- Rongxi Wang
- Phone Number: +8619800370331
- Email: pumch_jacobwong@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 68Ga-NOTA-RM26 PET/CT
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.
|
68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized uptake value of 68Ga-NOTA-RM26 in gastrointestinal stromal tumor
Time Frame: 1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events collection
Time Frame: 1 week
|
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Anticipated)
August 31, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
August 6, 2021
First Submitted That Met QC Criteria
August 6, 2021
First Posted (Actual)
August 11, 2021
Study Record Updates
Last Update Posted (Actual)
August 11, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Neoplasms, Connective Tissue
- Gastrointestinal Stromal Tumors
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- 68Ga-NOTA-RM26
Other Study ID Numbers
- PekingUMCH-NMRM26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Peking Union Medical College HospitalNational Institute for Biomedical Imaging and Bioengineering (NIBIB)Unknown