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Trial Title:
68Ga-NOTA-PEG2-RM26 PET/CT, First in Man Study
NCT ID:
NCT06147362
Condition:
Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-NOTA-PEG2-RM26
Description:
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.
Arm group label:
68Ga-NOTA-PEG2-RM26
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Antonios Tzortzakakis, MD, PhD
Phone:
08-123 80 000
Email:
antonios.tzortzakakis@regionstockholm.se
Investigator:
Last name:
Rimma Axelsson, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Antonios Tzortzakakis, MD, PhD
Email:
Sub-Investigator
Start date:
June 1, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
Stockholm South General Hospital
Agency class:
Other
Collaborator:
Agency:
Uppsala University
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06147362
