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

Sponsor
Karolinska University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06147362
Collaborator
Stockholm South General Hospital (Other), Uppsala University (Other)
50
Enrollment
1
Location
1
Arm
19
Anticipated Duration (Months)
2.6
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-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.

Condition or Disease Intervention/Treatment Phase
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. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Approximately ten patients (with primary/recurrent or metastatic cancer) in each of the following six cancer groups, prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, and lung cancer, will be recruited and examined.Approximately ten patients (with primary/recurrent or metastatic cancer) in each of the following six cancer groups, prostate cancer, breast cancer, colorectal cancer, gastrointestinal carcinoid, gastric cancer, and lung cancer, will be recruited and examined.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-NOTA-PEG2-RM26

Participants will be injected with 2 MBq/kg of 68Ga-NOTA-PEG2-RM26 limited to 100-200 MBq and then undergo PET/CT examination.

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.

Outcome Measures

Primary Outcome Measures

  1. Adverse events within 2 weeks of injection [2 weeks]

    Adverse events within 2 weeks of injection and scanning of participants

Secondary Outcome Measures

  1. Biodistribution of 68Ga-NOTA-PEG2-RM26 [During procedure]

    The semiquantitative analysis will be performed by the same person for all the cases, uptake in organs with uptake above the blood pool will bes described

  2. Dosimetry of 68Ga-NOTA-PEG2-RM26 [During procedure]

    Mean absorbed radiation doses will be estimated using the source and target organ framework outlined by the Medical Internal Radiation Dose Committee. Absorbed and effective radiation doses will be calculated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Primary/recurrent or metastatic cancer in: prostate cancer, breast cancer, colorectal cancer, 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 Group Performance Status Scale 0 or 1 and a negative pregnancy test

Exclusion Criteria:

  • Age less than 18 years

  • Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or transient 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 of contraception

  • Participation in any other clinical trial within the previous 4 weeks

  • Unable to comply with study procedures (e.g., claustrophobia, low back pain not allowing the patient to lay down in the examination bed)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden 17176

Sponsors and Collaborators

  • Karolinska University Hospital
  • Stockholm South General Hospital
  • Uppsala University

Investigators

  • Principal Investigator: Jeffrey Yachnin, MD, PhD, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey Yachnin M.D., PhD., Section Head Early Clinical Trial Unit, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT06147362
Other Study ID Numbers:
  • EudraCT 2021-004980-28
First Posted:
Nov 27, 2023
Last Update Posted:
Nov 27, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 27, 2023