68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

68Ga-NOTA-RM26 PET/CT for the Detection of Gastrointestinal Stromal Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001204
• Other study ID #: PekingUMCH-NMRM26
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2021
• Source: Peking Union Medical College Hospital
• Contact: Rongxi Wang
• Phone: +8619800370331
• Email: pumch_jacobwong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• 68Ga-NOTA-RM26
68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed	1 week