Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2022-06-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stockholm South General Hospital
OTHER
Uppsala University
OTHER
Karolinska University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeffrey Yachnin M.D., PhD.
Section Head Early Clinical Trial Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey Yachnin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karolinska University Hospital
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT 2021-004980-28
Identifier Type: -
Identifier Source: org_study_id