RetinoblastomaNCT02764398
Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia
An observational study of Retinoblastoma, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Retinoblastoma
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Nov 2015
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children requiring superselective ophthalmic artery chemotherapy for retinoblastoma
Who may be able to join
- superselective ophthalmic artery chemotherapy for retinoblastoma required
Who cannot join
- no
About this study
Official title: Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia
Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia and catheter stimulation might be a support cause of these SCRE.
Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma are prospectively included in this observational study. Endovascular procedures are performed under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension, bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence are investigated.
- Conditions
- Retinoblastoma
- Medical subject headings
- Retinoblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.
Measured: from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startDec 2013
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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 only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764398
- Sponsor's protocol ID
- NI_2016_1
- Status last verified
- May 2016
- First submitted
- 1 May 2016
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia
- ClinicalTrials.gov ID
- NCT02764398
- Acronym / sponsor ID
- NI_2016_1
- Conditions
- Retinoblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- First posted
- 6 May 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.
Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia and catheter stimulation might be a support cause of these SCRE.
Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma are prospectively included in this observational study. Endovascular procedures are performed under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension, bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence are investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children requiring superselective ophthalmic artery chemotherapy for retinoblastoma
Key inclusion criteria (1 listed)
- superselective ophthalmic artery chemotherapy for retinoblastoma required
Key exclusion criteria (1 listed)
- no
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
Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.
Time frame: from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes.
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 11 May 2016.
Related trials for Retinoblastoma
RecruitingObservational study
Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
Sarcoma, Endocrine Tumors
Active, not recruitingPhase 1
EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
Pediatric Solid Tumor, Germ Cell Tumor
Enrolling by invitationObservational study
Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
Survivors of Unilateral Retinoblastoma
RecruitingPhase 2
A Study to Give Treatment Inside the Eye to Treat Retinoblastoma
Bilateral Retinoblastoma, Childhood Intraocular Retinoblastoma
Enrolling by invitationPhase 1
GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma and Metastatic Retinoblastoma
Refractory Neuroblastoma, Relapsed Neuroblastoma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 1 inclusion and 1 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma. (time frame: from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes.). It is what the study was designed to measure, not a finding.
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 11 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.