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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05001204
Enrollment
30
Registered
2021-08-11
Start date
2021-05-01
Completion date
2022-08-31
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumors

Keywords

PET/CT, RM26, GRPR, gastrin-releasing peptide receptor

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).

Interventions

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value of 68Ga-NOTA-RM26 in gastrointestinal stromal tumor1 yearThe 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

MeasureTime frameDescription
Adverse events collection1 weekAdverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Countries

China

Contacts

Primary ContactRongxi Wang
pumch_jacobwong@163.com+8619800370331
Backup ContactZhaohui Zhu, MD
13611093752@163.com13611093752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026