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

Phase 1

Recruiting

• Conditions: Cancer
• Interventions: Drug: 68Ga-NOTA-PEG2-RM26

• Registration Number: NCT06147362
• Lead Sponsor: Karolinska University Hospital

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.

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 Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-23
• Last Update Submitted: 2023-11-23
• Study First Posted: 2023-11-27
• Last Update Posted: 2023-11-27
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-PEG2-RM26	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.

Primary Outcome Measures

Name	Time	Method
Adverse events within 2 weeks of injection	2 weeks	Adverse events within 2 weeks of injection and scanning of participants

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden