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

Last updated: November 23, 2023
Sponsor: Karolinska University Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Treatment

68Ga-NOTA-PEG2-RM26

Clinical Study ID

NCT06147362
EudraCT 2021-004980-28
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary/recurrent or metastatic cancer in: prostate cancer, breast cancer, colorectalcancer, gastrointestinal carcinoid, gastric cancer, or lung cancer
  • Histopathological diagnosis
  • Age 18 years or more and palliative disease OR age above 50 years
  • Adequate bone marrow, hepatic and renal function, Eastern Cooperative Oncology GroupPerformance Status Scale 0 or 1 and a negative pregnancy test

Exclusion

Exclusion Criteria:

  • Age less than 18 years
  • Less than 6 months since a clinically significant cardiovascular event such asmyocardial infarction, unstable angina, angioplasty, bypass surgery, stroke ortransient ischemic attack
  • Congestive heart failure New York Heart Association class ≥ II
  • Pregnant or breast-feeding women
  • Patients with reproductive potential not implementing accepted and effective means ofcontraception
  • Participation in any other clinical trial within the previous 4 weeks
  • Unable to comply with study procedures (e.g., claustrophobia, low back pain notallowing the patient to lay down in the examination bed)

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: 68Ga-NOTA-PEG2-RM26
Phase: 1
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2023

Study 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. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.

To target gastrin-releasing peptide receptor in human neoplastic cells NOTA-PEG2-RM26 was synthesised and then labeled with 68Ga.

An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-PEG2-RM26 and to assess its clinical diagnostic value in patients with cancer.

Connect with a study center

  • Karolinska University Hospital

    Stockholm, 17176
    Sweden

    Active - Recruiting

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