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OpenTrials
Completed

NCT Number: NCT02714465

Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy

Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery (GKS) by treatment with hyperbaric oxygen therapy (HBO)

Completed

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Key information

Conditions

Age range

10 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

About this study

Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma knife surgery, documented by both clinical examination (Rankin Scale) and instrumental imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they will have a break of 10-15 days during which also performs the instrumental survey (Magnetic Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment otherwise continue up to a maximum of 40 treatment sessions of HBO

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • between 10 and 75 years
  • understanding of the Italian language
  • ability to understand the procedures and carrying out of the study
  • signing informed consent for adults and minors in use
  • underwent radiosurgery with clinical and instrumental signs of radiation necrosis

Exclusion criteria

  • younger than 10yrs old and older than 75yrs old
  • not capable to understand Italian language or to understand the protocol procedures and visits' scheme
  • informed consent not given
  • enrolled in another clinical trial
  • concomitant pathologies contraindicate HBO as: emphysema, asthma, epilepsy, claustrophobia; Paul Bert Syndrome, Lorrain Smith Syndrome
  • under disulfiram, doxorubicine, cisplatinum, mafenide acetate, bleomycins treatment
  • life expectancy less than 6 months
  • Rankin Scale >5

Treatment and study plan

Hyperbaric Oxygen Therapy

Other

hyperbaric oxygen therapy

Primary outcomes

  1. Evaluation of clinical improvement

    Time frame: day 2 through day 25

    By neurological evaluation (Ranking Scale)

Secondary outcomes

  1. Evaluation of the reduction of the extent of edema lesion documented by MRI

    Time frame: 1-3 months

    MRI analysis

  2. Measurement of complications from hyperbaric oxygen therapy and their severity

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Treatment of Adverse Radiation Effects After Gamma Knife Radiosurgery (GKS) by Hyperbaric Oxygen Therapy (HBO)

Acronym: GKSHBO

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Mar 21, 2016
Registry last updated
Mar 22, 2023

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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