uPAR-PET/MRI in Glioblastoma Multiforme

Study Purpose

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery.
  • - The participants must be capable of understanding and giving full informed written consent.
  • - age above 18 years.

Exclusion Criteria:

  • - Pregnancy.
  • - Lactation/breast feeding.
  • - Age above 85 years old.
  • - Weight above 140 kg.
- Known allergy towards 68Ga-NOTA-AE105

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02945826
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rigshospitalet, Denmark
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dorthe Skovgaard, Md, PhD
Principal Investigator Affiliation Rigshospitalet, Denmark
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival

Arms & Interventions

Arms

Experimental: uPAR PET/MRI

One injection of 68Ga-NOTA-AE105 followed by PET/MRI.

Interventions

Drug: - One injection of 68Ga-NOTA-AE105

One injection of 68Ga-NOTA-AE105

Device: - PET/MRI

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Copenhagen, Denmark

Status

Recruiting

Address

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, , 2100

Site Contact

Dorthe Skovgaard, MD, Phd

dskovgaard@dadlnet.dk

+4561274706

Stay Informed & Connected