68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study

NCT06147362 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-27

No results posted yet for this study

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-PEG2-RM26 in prostate cancer patients. A single dose of 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq per examination will be given intravenously. Visual and semiquantitative method will be used to assess PET/CT images.

Conditions

Interventions

DRUG

68Ga-NOTA-PEG2-RM26

Single-dose 68Ga-NOTA-PEG2-RM26, a gastrin-releasing peptide receptor antagonist linked with a positron emitting radioisotope intravenously injected into participants before the PET/CT scans.

Sponsors & Collaborators

  • Stockholm South General Hospital

    collaborator OTHER
  • Uppsala University

    collaborator OTHER
  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Jeffrey Yachnin, MD, PhD · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147362 on ClinicalTrials.gov