Cervical CancerDETECTNCT02083848
Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI
A study testing 7T MRI in people with Cervical Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Background of the study: The accurate assessment of local cervical cancer spread (i.e. invasion) is of clinical importance for staging and treatment considerations. For example, if parametrial invasion is absent, radical surgery is the treatment of choice for tumors less than 4cm in diameter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- 7T MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Nov 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary malignancy of the cervix uteri;
- FIGO stage IB1, IB2, IIA or IIB;
- ≥18 years;
- Written inform consent provided.
Who cannot join
- Contra-indications for MRI: Any non-removable electronic or ferromagnetic object present in the body; Pregnancy; Severe claustrophobia; Unable to lie still and completely horizontal for minimally 45 minutes;
- Body weight >150kg;
- Any type of neo-adjuvant chemo- and/or radiotherapy for cervical cancer;
- Uterine prolapse with C ≥ -6 cm (POP-Q).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI (DETECT)
Background of the study: The accurate assessment of local cervical cancer spread (i.e. invasion) is of clinical importance for staging and treatment considerations. For example, if parametrial invasion is absent, radical surgery is the treatment of choice for tumors less than 4cm in diameter. However, if such invasion is present, the patient has become inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively frequent false-negative findings a risk of understaging and under-treatment occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery, causing increased morbidity and treatment associated risks. For higher stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable individualized dose(volume) and field modifications.
Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI sequences, which use a combination of an endorectal and external coil, to image the (para)cervical area for assessment of the loco-regional tumor status in cervical cancer.
Read more
Study design: The proposed study is an investigator initiated, single center, prospective pilotstudy.
Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of IIB will be included.
Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI sequences of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.
Read the detailed description
See brief summary
- Conditions
- Cervical Cancer
- Being tested
- 7T MRI
- Keywords
- Locoregional invasion, Stage IB1, IB2, IIA or IIB
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRIOther
Ultra high field magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| 7T MRI | Other | All subjects are entered into a single arm. Receives: Other: 7T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimized T2w ultra high field (7T) MRI sequence of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.
This is a feasibility outcome (feasibility study). This pilot study does not aim to test diagnostic accuracy. The (feasibility) criteria when this 7T MRI protocol is deemed optimized are:
- Successful depiction, at minimum, of the anatomy present in the inner pelvis (at the cervical level) in three orthogonal planes;
- Sufficient T2w contrast in the created datasets for clinical diagnostic applicability. This includes sufficient T2w contrast within the cervix to be able to delineate its subanatomy (e.g. mucosa vs. fibrous tissue);
- Absence of image distorting artefacts, which reduce the clinical diagnostic applicability, regardless of their cause;
- The overall protocol does not exceed 45 minutes of scan time;
- Reproducibility of the above mentioned criteria.
Measured: Up to 2 years from study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W.B. Veldhuis, MD PhD, UMC Utrecht
- Investigators
- Jacob P Hoogendam, MD, Study director, UMC UtrechtWouter B Veldhuis, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083848
- Sponsor's protocol ID
- NL41056.041.13
- Acronym
- DETECT
- Status last verified
- Nov 2015
- First submitted
- 4 Mar 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI (DETECT)
- ClinicalTrials.gov ID
- NCT02083848
- Acronym / sponsor ID
- DETECT / NL41056.041.13
- Conditions
- Cervical Cancer
- Keywords
- Locoregional invasion, Stage IB1, IB2, IIA or IIB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Mar 2014 (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 of the study: The accurate assessment of local cervical cancer spread (i.e. invasion) is of clinical importance for staging and treatment considerations. For example, if parametrial invasion is absent, radical surgery is the treatment of choice for tumors less than 4cm in diameter. However, if such invasion is present, the patient has become inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to relatively frequent false-negative findings a risk of understaging and under-treatment occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the initial surgery, causing increased morbidity and treatment associated risks. For higher stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local tumor spread could enable individualized dose(volume) and field modifications.
Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI sequences, which use a combination of an endorectal and external coil, to image the (para)cervical area for assessment of the loco-regional tumor status in cervical cancer.
Study design: The proposed study is an investigator initiated, single center, prospective pilotstudy.
Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA of IIB will be included.
Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI sequences of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.
Detailed description
See brief summary
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7T MRI | Other | Other: 7T MRIAll subjects are entered into a single arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven primary malignancy of the cervix uteri;
- FIGO stage IB1, IB2, IIA or IIB;
- ≥18 years;
- Written inform consent provided.
Key exclusion criteria (4 listed)
- Contra-indications for MRI: Any non-removable electronic or ferromagnetic object present in the body; Pregnancy; Severe claustrophobia; Unable to lie still and completely horizontal for minimally 45 minutes;
- Body weight >150kg;
- Any type of neo-adjuvant chemo- and/or radiotherapy for cervical cancer;
- Uterine prolapse with C ≥ -6 cm (POP-Q).
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 |
|---|---|---|
| 7T MRIUltra high field magnetic resonance imaging | Other | 7T MRI |
Primary outcome
Optimized T2w ultra high field (7T) MRI sequence of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer.
Time frame: Up to 2 years from study initiation
This is a feasibility outcome (feasibility study). This pilot study does not aim to test diagnostic accuracy. The (feasibility) criteria when this 7T MRI protocol is deemed optimized are: * Successful depiction, at minimum, of the anatomy present in the inner pelvis (at the cervical level) in three orthogonal planes; * Sufficient T2w contrast in the created datasets for clinical diagnostic applicability. This includes sufficient T2w contrast within the cervix to be able to delineate its subanatomy (e.g. mucosa vs. fibrous tissue); * Absence of image distorting artefacts, which reduce the clinical diagnostic applicability, regardless of their cause; * The overall protocol does not exceed 45 minutes of scan time; * Reproducibility of the above mentioned criteria.
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 3 Nov 2015.
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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.
Jacob P Hoogendam, MD study director
UMC Utrecht
Wouter B Veldhuis, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7T MRI in people with Cervical Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 4 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 3 Nov 2015. 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 Netherlands. 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?
Optimized T2w ultra high field (7T) MRI sequence of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer. (time frame: Up to 2 years from study initiation). 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 3 Nov 2015.