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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05001204

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: 68Ga-NOTA-RM26	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

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.

Drug: 68Ga-NOTA-RM26

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

Outcome Measures

Primary Outcome Measures

Standardized uptake value of 68Ga-NOTA-RM26 in gastrointestinal stromal tumor [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.

Secondary Outcome Measures

Adverse events collection [1 week]
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.