Analysis of CMV Infections in Patients With Brain Tumors or Brain Metastases During and After Radio(Chemo)Therapy

Study Purpose

Radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. Neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. However CMV encephalitis may also be a reason. Therefore the investigators aim to analyze the CMV status in patients during and after radio(chemo)therapy. It will be checked by CMV-DNA (PCR analysis) and CMV antibodies (IgG and IgM ELISA) in the blood of the patients. These findings will be correlated with changes in the brain, visualized by MRI. In addition a detailed immunophenotyping in the peripheral blood will be performed.

Recruitment Criteria

Accepts Healthy Volunteers

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

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.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - brain tumours (glioblastoma or anaplastic astrocytoma) - brain metastases from diagnosed primary tumours.
  • - legal age.
  • - planned chemoradiation and adjuvant chemotherapy [metastases] - planned chemoradiation and adjuvant chemotherapy with temodal (according to Stupp et.
al.) [brain tumors]

Exclusion Criteria:

  • - fertile patients who refuse effective contraception during study treatment.
  • - persistent drug and/or alcohol abuse.
  • - patients not able or willing to behave according to study protocol.
  • - patients in care.
  • - patients that are not able to speak German.
  • - patients with claustrophobia.
  • - patients with artificial joint or any metal parts in the body.
- patients with pacemakers

Trial Details

Trial ID:

This trial id was obtained from, 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.


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.

Lead Sponsor

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

University of Erlangen-Nürnberg Medical School
Principal Investigator

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

Rainer Fietkau, Prof.
Principal Investigator Affiliation Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Agency Class

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

Overall Status Recruiting
Countries Germany

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

Cytomegalovirus Infections
Arms & Interventions


: Study cohort

All patients who are suffering from brain tumor of brain metastases and are willing to participate. The treatment-plan of the underlying disease remained unchanged. Blood draw and MRI from patients at several time points during and after radio(chemo)therapy.


Other: - Blood draw and MRI

The study is observational. The treatment-plan of the underlying disease remained unchanged. Blood draw and MRI from patients at several time points during and after radio(chemo)therapy.

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

Erlangen, Bavaria, Germany




Departement of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität erlangen-Nürnberg

Erlangen, Bavaria, 91054

Site Contact

Rainer Fietkau, Prof.

+49 9131 85 33405

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