Arteriovenous MalformationNCT00603694
Hippocampal Radiation Exposure and Memory
An observational study of Arteriovenous Malformation and Schwannoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Malformation, Schwannoma, Trigeminal Neuralgia
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have consented to GK radiosurgery or cranial radiation.
Who may be able to join
- Patients planned for radiosurgery for benign disorders (Groups 1\&2).
- Patients planned for prophylactic cranial irradiation (Group 3)
Who cannot join
- Previous cranial radiation
- Severe psychiatric disorder
- Severe cognitive or memory impairment (MMSE < 21)
- Non-English speaking, which will potentially make memory testing difficult and unreliable.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures
- Patients on steroid medications.
Show all 11Show fewer
- Left hand dominant patients
- Dose exposure to left hippocampus >0.5Gy and <2Gy. We will attempt to estimate dose to hippocampus prior to enrollment using pre-planning on diagnostic imaging to minimize exclusion of patients due to dose exposure >0.5 Gy and < 2Gy following baseline memory testing.
- Benzodiazepine or narcotics given on the day of radiotherapy/radiosurgery prior to completion of the study procedures
- Previous brain surgery within one year prior to radiosurgery
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Canada1 site
Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Hippocampal Radiation Exposure and Memory: A Pilot Study
Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.
In this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.
- Conditions
- Arteriovenous Malformation, Schwannoma, Trigeminal Neuralgia
- Keywords
- Hippocampus, Memory, Radiation
- Medical subject headings
- Arteriovenous Malformations, Neurilemmoma, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | (Experimental group): Receiving > 2 Gy SRS to left hippocampus (n=10) | |
| 2 | (Low-dose control group): Receiving < 0.5 Gy SRS to left hippocampus (n=10) | |
| 3 | (High-dose control group): Receiving whole brain PCI (n=10) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603694
- Sponsor's protocol ID
- 07-0023-CE
- Status last verified
- Jun 2016
- First submitted
- 16 Jan 2008
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal Radiation Exposure and Memory: A Pilot Study
- ClinicalTrials.gov ID
- NCT00603694
- Acronym / sponsor ID
- 07-0023-CE
- Conditions
- Arteriovenous Malformation, Schwannoma, Trigeminal Neuralgia
- Keywords
- Hippocampus, Memory, Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.
In this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –(Experimental group): Receiving > 2 Gy SRS to left hippocampus (n=10) |
| 2 | – | –(Low-dose control group): Receiving < 0.5 Gy SRS to left hippocampus (n=10) |
| 3 | – | –(High-dose control group): Receiving whole brain PCI (n=10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have consented to GK radiosurgery or cranial radiation.
Key inclusion criteria (2 listed)
- Patients planned for radiosurgery for benign disorders (Groups 1\&2).
- Patients planned for prophylactic cranial irradiation (Group 3)
Key exclusion criteria (11 listed)
- Previous cranial radiation
- Severe psychiatric disorder
- Severe cognitive or memory impairment (MMSE < 21)
- Non-English speaking, which will potentially make memory testing difficult and unreliable.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Malformation and Schwannoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.