Cavernous Sinus MeningiomaISOMABNCT02750371
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
A study testing Evaluation of autobiographical memory in people with Cavernous Sinus Meningioma and Pituitary Adenoma, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Cavernous Sinus Meningioma, Pituitary Adenoma
- What is being tested?
- Evaluation of autobiographical memory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2016to Mar 2022
- Phase
- Interventional
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35 and 65.
- Patient with:
- meningioma of the cavernous sinus for which radiotherapy is planned
- or a pituitary adenoma for which radiotherapy is planned
- French Mother tongue
- Person affiliated to national insurance
- Person who give its verbal agreement to participate
Who cannot join
- Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.).
- Treatment with chemotherapy
- General intellectual abilities deficient (IQ <80)
- Extension front of their meningioma
- Deficient Language Skills.
Trial locations and contacts
1 site in 1 country.
About this study
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.
However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.
The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.
Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.
Read the detailed description
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory.
Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments.
The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.
A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma.
Investigators hope for confirm our results from pilot study.
- Conditions
- Cavernous Sinus Meningioma, Pituitary Adenoma
- Being tested
- Evaluation of autobiographical memory
- Keywords
- Cavernous sinus meningioma, Pituitary adenoma, Hippocampus, Irradiation, Autobiographical memory
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of autobiographical memoryOther
Patients will answer several questionnaires one and two years after irradiation treatment end.
| Study group | Role | What they receive |
|---|---|---|
| Patients with brain tumors treated by radiotherapy | Experimental | Patients with:
- meningioma of the cavernous sinus for which radiotherapy is planned
Or
- a pituitary adenoma for which radiotherapy is planned Receives: Other: Evaluation of autobiographical memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autobiographical memory test (TEMPau) score
Measured: Two years after irradiation treatment end
Secondary outcomes (4)
Autobiographical memory test (TEMPau) score
Measured: One year after irradiation treatment end
Revised Self Consciousness Scale (RSCS) score
Measured: One and two years after irradiation treatment end
Quality of life questionnaire (QLQC-30/BN20) score
Measured: One and two years after irradiation treatment end
California Verbal Learning Test (CVLT) score
Measured: One and two years after irradiation treatment end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start27 Jul 2016
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cavernous Sinus MeningiomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BRANCHARD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750371
- Sponsor's protocol ID
- CHUBX 2015/03
- Acronym
- ISOMAB
- Status last verified
- Mar 2023
- First submitted
- 20 Apr 2016
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).
Publications
Nadel L, Moscovitch M. Memory consolidation, retrograde amnesia and the hippocampal complex. Curr Opin Neurobiol. 1997 Apr;7(2):217-27. doi: 10.1016/s0959-4388(97)80010-4.
PubMed 9142752Cabeza R, St Jacques P. Functional neuroimaging of autobiographical memory. Trends Cogn Sci. 2007 May;11(5):219-27. doi: 10.1016/j.tics.2007.02.005. Epub 2007 Mar 26.
PubMed 17382578Mizumatsu S, Monje ML, Morhardt DR, Rola R, Palmer TD, Fike JR. Extreme sensitivity of adult neurogenesis to low doses of X-irradiation. Cancer Res. 2003 Jul 15;63(14):4021-7.
PubMed 12874001Sans C, Dupin C, Huchet A, Branchard O, Nunes ML, Vendrely V, Loiseau H, Planchon C. [Prospective longitudinal study on the evolution of autobiographical memory in patients irradiated for benign skull base tumour]. Cancer Radiother. 2024 Aug;28(4):309-316. doi: 10.1016/j.canrad.2023.11.003. Epub 2024 Jun 24. French.
PubMed 38918132
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
- ClinicalTrials.gov ID
- NCT02750371
- Acronym / sponsor ID
- ISOMAB / CHUBX 2015/03
- Conditions
- Cavernous Sinus Meningioma, Pituitary Adenoma
- Keywords
- Cavernous sinus meningioma, Pituitary adenoma, Hippocampus, Irradiation, Autobiographical memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 25 Apr 2016 (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.
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes.
However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus.
The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.
Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.
Detailed description
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory.
Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments.
The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory.
A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma.
Investigators hope for confirm our results from pilot study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with brain tumors treated by radiotherapy | Experimental | Other: Evaluation of autobiographical memoryPatients with: - meningioma of the cavernous sinus for which radiotherapy is planned Or - a pituitary adenoma for which radiotherapy is planned |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 35 and 65.
- Patient with:
- French Mother tongue
- Person affiliated to national insurance
- Person who give its verbal agreement to participate
Key exclusion criteria (5 listed)
- Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.).
- Treatment with chemotherapy
- General intellectual abilities deficient (IQ <80)
- Extension front of their meningioma
- Deficient Language Skills.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of autobiographical memoryPatients will answer several questionnaires one and two years after irradiation treatment end. | Other | Patients with brain tumors treated by radiotherapy |
Primary outcome
Autobiographical memory test (TEMPau) score
Time frame: Two years after irradiation treatment end
4 secondary outcomes
Autobiographical memory test (TEMPau) score
Time frame: One year after irradiation treatment end
Revised Self Consciousness Scale (RSCS) score
Time frame: One and two years after irradiation treatment end
Quality of life questionnaire (QLQC-30/BN20) score
Time frame: One and two years after irradiation treatment end
California Verbal Learning Test (CVLT) score
Time frame: One and two years after irradiation treatment end
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 14 May 2026.
- Background: PubMed 9142752Nadel L, Moscovitch M. Memory consolidation, retrograde amnesia and the hippocampal complex. Curr Opin Neurobiol. 1997 Apr;7(2):217-27. doi: 10.1016/s0959-4388(97)80010-4.
- Background: PubMed 17382578Cabeza R, St Jacques P. Functional neuroimaging of autobiographical memory. Trends Cogn Sci. 2007 May;11(5):219-27. doi: 10.1016/j.tics.2007.02.005. Epub 2007 Mar 26.
- Background: PubMed 12874001Mizumatsu S, Monje ML, Morhardt DR, Rola R, Palmer TD, Fike JR. Extreme sensitivity of adult neurogenesis to low doses of X-irradiation. Cancer Res. 2003 Jul 15;63(14):4021-7.
- Results publication: PubMed 38918132Sans C, Dupin C, Huchet A, Branchard O, Nunes ML, Vendrely V, Loiseau H, Planchon C. [Prospective longitudinal study on the evolution of autobiographical memory in patients irradiated for benign skull base tumour]. Cancer Radiother. 2024 Aug;28(4):309-316. doi: 10.1016/j.canrad.2023.11.003. Epub 2024 Jun 24. French.
- Individual participant dataSharing planned: No. Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).
Related trials for Cavernous Sinus Meningioma
Recruiting
Long-term Cognitive and Functional Impact of Proton-therapy or Modern Fractionated Radiotherapy in Cavernous Sinus Meningioma: An Open-label Randomized 1:1 Phase III Study
Cavernous Sinus Meningioma, Proton-therapy
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.
Olivier BRANCHARD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of autobiographical memory in people with Cavernous Sinus Meningioma and Pituitary Adenoma, run by University Hospital, Bordeaux at 1 site in France.
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 7 inclusion and 5 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 14 May 2026. 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 France. 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.
What does the primary outcome measure?
Autobiographical memory test (TEMPau) score (time frame: Two years after irradiation treatment end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750371, which also lists 4 linked publications.
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 14 May 2026.