CraniopharyngiomaNCT01206543
1.5T Intraoperative MR Imaging in Craniopharyngiomas
A study testing Intraoperative imaging using 1.5T MRI in people with Craniopharyngioma, run by Hofmann, Bernd, M.D. at 1 site in Germany.
Trial summary
Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Craniopharyngioma
- What is being tested?
- Intraoperative imaging using 1.5T MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2002to Aug 2006
- 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 3 to 75 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- complex craniopharyngioma > 1cm extension within 2 or more cranial fossae or ventricular system
- Patient or legal representative able to provide written informed consent
Who cannot join
- tumor size< 1 cm
- Patients with any condition considered a contraindication to MRI
- Patients with any condition considered a contraindication for surgery
- Hypothalamic disturbances
- Hypothalamic edema
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurosurgery University of Erlangen
Erlangen, 91052
About this study
Official title: Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System")
Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.
- Conditions
- Craniopharyngioma
- Being tested
- Intraoperative imaging using 1.5T MRI
- Keywords
- Craniopharyngioma, Surgery, Intraoperative imaging, Rate of total removal
- Medical subject headings
- Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative imaging using 1.5T MRIOther
Intraoperative imaging and determination of degree of resection / complete tumor removal
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative imaging | Experimental | Not described Receives: Other: Intraoperative imaging using 1.5T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of additional tumor removal
Number of patients in whom non suspected tumor remants were indicated by intraoperative MRI and remnants could be removed completely thereafter. Results have to be confirmed in 1st follow up imaging.
Measured: up to 3-4 months following surgery
Rate of achievement of intended extent of removal
It is examined whether the extent of tumor removal defined prior to surgery was achieved
Measured: up to three months following surgery
Diagnostic reliability
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
Measured: within 3 -4 months following surgery
Secondary outcomes (1)
Surgical complication
Rate of new deficits following surgery (excluding new endocrine deficits)
Measured: within 1st week following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startApr 2002
- Primary completionSep 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofmann, Bernd, M.D.
- Investigators
- Bernd Hofmann, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206543
- Sponsor's protocol ID
- Cranio 15
- Status last verified
- Sep 2010
- First submitted
- 20 Sep 2010
- Last updated
- 22 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System")
- ClinicalTrials.gov ID
- NCT01206543
- Acronym / sponsor ID
- Cranio 15
- Conditions
- Craniopharyngioma
- Keywords
- Craniopharyngioma, Surgery, Intraoperative imaging, Rate of total removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hofmann, Bernd, M.D.
- Study start
- Apr 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Sep 2010 (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.
Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative imaging | Experimental | Other: Intraoperative imaging using 1.5T MRI |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- complex craniopharyngioma > 1cm extension within 2 or more cranial fossae or ventricular system
- Patient or legal representative able to provide written informed consent
Key exclusion criteria (5 listed)
- tumor size< 1 cm
- Patients with any condition considered a contraindication to MRI
- Patients with any condition considered a contraindication for surgery
- Hypothalamic disturbances
- Hypothalamic edema
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 |
|---|---|---|
| Intraoperative imaging using 1.5T MRIIntraoperative imaging and determination of degree of resection / complete tumor removal | Other | Intraoperative imaging |
Primary outcome
Rate of additional tumor removal
Time frame: up to 3-4 months following surgery
Number of patients in whom non suspected tumor remants were indicated by intraoperative MRI and remnants could be removed completely thereafter. Results have to be confirmed in 1st follow up imaging.
Rate of achievement of intended extent of removal
Time frame: up to three months following surgery
It is examined whether the extent of tumor removal defined prior to surgery was achieved
Diagnostic reliability
Time frame: within 3 -4 months following surgery
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
1 secondary outcome
Surgical complication
Time frame: within 1st week following surgery
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 22 Sep 2010.
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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.
Bernd Hofmann, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative imaging using 1.5T MRI in people with Craniopharyngioma, run by Hofmann, Bernd, M.D. at 1 site in Germany.
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 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 22 Sep 2010. 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 Germany. 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?
Rate of additional tumor removal (time frame: up to 3-4 months following surgery). The study lists 3 primary outcomes in all. 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 22 Sep 2010.