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

Cancer Clinical Trial

Official title:

68Ga-NOTA-PEG2-RM26 PET/CT: Tracer Biodistribution and Uptake in Different Kinds of Cancer With Gastrin-Releasing Peptide Receptor (GRPR) Overexpression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147362
• Other study ID #: EudraCT 2021-004980-28
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Karolinska University Hospital
• Contact: Antonios Tzortzakakis, MD, PhD
• Phone: 08-123 70 000
• Email: antonios.tzortzakakis[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Stockholm South General Hospital, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events within 2 weeks of injection	Adverse events within 2 weeks of injection and scanning of participants	2 weeks
Secondary	Biodistribution of 68Ga-NOTA-PEG2-RM26	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	During procedure
Secondary	Dosimetry of 68Ga-NOTA-PEG2-RM26	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.	During procedure