68Ga-NOTA-RM26 PET/CT in Prostate Cancer Patients

NCT03164837 — Phase 1, Unknown, 30 participants, Peking Union Medical College Hospital

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Safety and Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Prostate Cancer Patients

Registry	NCT03164837
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	30 (Estimated)
Sponsor	Peking Union Medical College Hospital (Other); collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions	Prostate Cancer
Interventions	68Ga-NOTA-RM26 (Drug)
Dates	start 2016-11-01, primary completion 2018-11-01 (estimated), completion 2018-11-01 (estimated), first posted 2017-05-24, last updated 2017-05-24
Locations	1 site in China

-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 prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-RM26 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

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+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 prostate 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 prostate 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 investigate the safety and dosimetry of 68Ga-NOTA-RM26 and to assess its clinical diagnostic value in patients with prostate cancer.

+Arms and interventions

Arm	Type	Interventions	Description
68Ga-NOTA-RM26 PET/CT	Experimental	Drug: 68Ga-NOTA-RM26	The patients were injected with 111-148 MBq of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 15-30 min later.

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

+Outcome measures

Primary outcomes

Standardized uptake value of 68Ga-NOTA-RM26 in prostate cancer [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 prostate cancer will be measured.

Secondary outcomes

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

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* Patients with diagnosis of primary prostate cancer having a prostate neoplasm identified by ultrasound or MRI, being diagnosed by needle biopsy as having prostate cancer, having undergone whole-body bone scanning, and being able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

* The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

+Locations (1)

Facility	City	Country	Status
Peking Union Medical College Hospital	Beijing, Beijing Municipality	China	Recruiting

+Investigators

Zhaohui Zhu, M.D.,PhD., Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

+Funding

NIH grants: ZIAEB000073

My Notes

Public

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