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Completed

NCT Number: NCT02791360

Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse

Caen, 14400, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In the case group:

  • A history of solid brain tumor or haematological histologically proven.
  • Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
  • Radiotherapy treatment on a tumor in place or operated.
  • Decline at least 10 years from the end of radiotherapy.
  • Treatment with isocentric conformal radiotherapy.
  • No other radiation therapy for locally recurrent brain metastases or new brain tumor.
  • Lack of known brain metastases or meningeal carcinomatosis.

For the control group:

  • Patients previously treated for cancer and disease relapse free for 10 years.
  • No brain radiotherapy treatment.
  • Lack of treatment with anti-cancer chemotherapy.
  • Women of childbearing potential must be under effective contraception.
  • Pairing according to age, sex, arms director and socio-cultural level.

For two groups:

  • Man or woman aged (e) of minimum 18 years.
  • Topic fluent French and comprising well.
  • Free and Informed Consent signed.
  • The subject should be affiliated to an appropriate social security system
  • No cons-indication to MRI.
  • The subject must have at least one primary school level

Exclusion criteria

In the case group:

  • Brain radiotherapy carried out by intensity modulation technique.
  • Radiation dose less than 36 Gy on the brain.
  • Subject with against-indication to MRI.

For the control group:

  • Previous history of brain radiotherapy.
  • Previous history of brain surgery.
  • Central neurological disorders, such as seizures, uncontrolled.

For two groups:

  • Current Topics in oral chemotherapy or intravenous.
  • Subject pregnant.
  • Subject is not fluent in French or including bad.
  • Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
  • Participation in a therapeutic trial for less than 30 days.
  • A person not affiliated with a social security scheme.

Treatment and study plan

Brain MRI

Other

Primary outcomes

  1. Proportion of patient with MRI abnormality

    Time frame: up to 4 weeks

    To evaluate the proportion of patients with at least one abnormality on an imaging test

Secondary outcomes

  1. MRI diffusion abnormality

    Time frame: up to 4 weeks

  2. MRI perfusion abnormality

    Time frame: up to 4 weeks

  3. MRI vascular morphologic abnormalities

    Time frame: up to 4 weeks

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: TCSEQ

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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