68Ga-NOTA-RM26 PET/CT in Breast Tumor Patients

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03347864

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.3

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 breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Condition or Disease	Intervention/Treatment	Phase
Breast Tumor	Drug: 68Ga-NOTA-RM26	Early Phase 1

Detailed Description

The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to assess its clinical diagnostic value in patients with breast tumor.

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:

Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Breast Tumor Patients

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-NOTA-RM26 PET/CT The patients were injected with 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 30-45 min later	Drug: 68Ga-NOTA-RM26 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans

Arm

Intervention/Treatment

Experimental: 68Ga-NOTA-RM26 PET/CT

The patients were injected with 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 30-45 min later

Drug: 68Ga-NOTA-RM26

1.85 MBq per kilogram body weight of 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 breast tumor [1 year]
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor 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 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

patients in suspicion of breast cancer by mammography 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Study Chair: Zhaohui Zhu, MD,PHD, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03347864

Other Study ID Numbers:

PekingUMCH-NM15

First Posted:

Nov 20, 2017

Last Update Posted:

Nov 20, 2017

Last Verified:

Nov 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

68Ga-NOTA-RM26

Study Results

No Results Posted as of Nov 20, 2017