The purpose of this study is to assess the feasibility of the clinical use of 3T MR imaging for early glottic carcinoma.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the feasibility of the clinical use of 3T MR imaging of early
laryngeal carcinoma;
- Systematic assessment of technical image quality and assessment of tumour
visibility on 3T MRI.
- Anteroposterior tumour extension, lateral tumour extension (measured from
free edge of the vocal fold in mm), estimated tumour infiltration depth (mm)
and estimated tumour volume (cc) after delineation of the tumour at 3T MRI by
an experienced head and neck radiologist.
- Anteroposterior tumour extension and lateral tumour extension (measured from
free edge of the vocal fold in mm) during direct suspension laryngoscopy
(reference standard).
- Tumour infiltration depth (in mm and invasion of tissue layer: superficial
lamina propria, epithelium, Reinke*s space, vocal ligament, vocalis muscle) on
structured histopathologic examination.
- Anteroposterior tumour extension, lateral tumour extension (mm), infiltration
depth (mm) and estimated tumour volume (cc) on Computed Tomography, after
delineation of the tumour by an experienced head and neck radiologist.
Secondary outcome
Not applicable
Background summary
CO2 endoscopic laser surgery and radiotherapy are the main treatment modalities
for early glottic carcinoma (Tis and T1a/b). Regarding the national guideline
'Larynxcarcinoom' (NWHHT) CO2 endoscopic cordectomy is indicated for
superficial T1a midcord lesions. When the AC is involved, the contralateral
vocal cord is affected (T1b), or T1a lesions extend into the deeper layers of
the lamina propria or vocal muscle, CO2 laser surgery is expected to result in
worse functional outcome, and therefore radiotherapy in advocated. Up to now,
endoscopic evaluation under general anaesthesia is the reference standard to
assess tumour extension. CT is routinely performed to evaluate subglottic or
paraglottic and extralaryngeal extension. However, vizualisation of small
primary tumours may be difficult. The lack of information on the extent of the
tumour might lead to an underestimation of the extent of tumour with or without
AC involvement, resulting in unfavourable treatment. MR imaging is not
regularly performed in early glottic carcinoma, but a small pilot study shows
promising results. A renewed imaging protocol of 3 Tesla MRI is expected to be
of complementary value for detection of tumour extension in early glottic
carcinoma.
Study objective
The purpose of this study is to assess the feasibility of the clinical use of
3T MR imaging for early glottic carcinoma.
Study design
Prospective, non-randomized, feasibility study
Study burden and risks
Additional to routine staging protocol, 3T MRI will be scheduled. 3T MRI and
gadolinium based contrast are considered safe. MRI's will be scheduled in
combination with a regular appointment, if feasible.
To minimize the risk of movement artefacts and optimize image quality, a mask
that covers the region from the chin to the shoulders is prepared for each
patient. This mask is similar to the 5-point stabilization mask used for head
and neck radiotherapy, but not covering the face, minimizing patient
discomfort.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with primary clinical Tis, T1a and T1b glottic carcinoma, scheduled for treatment with CO2 laser therapy or radiotherapy
- Capablility of written informed consent
- Written informed consent
Exclusion criteria
- Patients with a history of previous glottic surgery
- Patients with recurrence of glottic disease
- Legal incapability
- Insufficient command of the Dutch language
- Patients with body implants, not compatible with MRI
- Patients with Claustrofobia
- Pregnant patients
- Creatinine clearance of <50mL/min/1.73m²
- Known allergy for Gadovist or Iodinated contrast
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48196.041.14 |