To study the diagnostic capacity of DW-MRI for detecting recurrence in patients with suspicion of recurrent or persistent HNSCC after initial (chemo)radiation. This study aims to enhance early, low cost detection of recurrence and avoid futileā¦
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Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of the study is the presence or absence of histological validated
recurrent HNSCC within 6 months after the suspicion. The diagnostic performance
of DW-MRI for the detection of recurrence in patients with clinical suspicion
of recurrent or persistent HNSCC after initial (chemo)radiation as reflected by
the positive predictive value, negative predictive value, sensitivity and
specificity of DW-MRI.
Secondary outcome
Secondary endpoints are the number of futile biopsy procedures if DW-MRI would
be used as selection strategy and the extra yield by DW-MRI; the number of
patients with a histological proven recurrence whereby DW-MRI was positive and
regular imaging was negative. In addition the missed recurrences with DW-MRI;
the number of patients with histological recurrence within 6 months whereby the
DW-MRI was negative.
Background summary
Post-radiation changes make diagnosis of recurrent or persistent head and neck
squamous cell carcinomas (HNSCC) after (chemo)radiation challenging. Imaging
modalities such as CT and conventional MRI often have difficulties
discriminating between post-radiation changes and tumour recurrence. Metabolic
imaging such as FDG-PET has additional value, but limitations due to low
spatial resolution and false-positive results caused by inflammatory disease
remain. Recent studies have shown that diffusion weighted MRI (DW-MRI) could be
an imaging modality with promising capacity in differentiating between
recurrence and post-radiation changes. Increased differentiation might lead to
a reduction of futile biopsies with need of an endoscopy under general
anaesthesia. Moreover, DW-MRI might allow early diagnosis of recurrence.
Study objective
To study the diagnostic capacity of DW-MRI for detecting recurrence in patients
with suspicion of recurrent or persistent HNSCC after initial (chemo)radiation.
This study aims to enhance early, low cost detection of recurrence and avoid
futile biopsies with need for general anaesthesia.
Study design
A prospectively designed diagnostic study to evaluate the diagnostic capacities
of DW-MRI in patients with suspicion of recurrent or persistent HNSCC. All
consecutive patients suspected of recurrent or persistent HNSCC in the UMC
Utrecht will receive a DW-MRI added to the regular imaging. If either the
regular imaging or the DW-MRI is suggestive for recurrence, biopsy will follow
for histological confirmation. If the regular imaging and DW-MRI are both
negative, patients remain in expectative follow up as in the regular protocol.
Reference standard is presence or absence of a histological proven recurrence
within 6 months after the suspicion.
Study burden and risks
Apart from regular imaging modality (CT, MRI or FDG-PET scan) patients will
undergo DW-MRI. No relevant risks associated with MRI for patients without
contra-indication and a normal renal function have been reported. The DW-MRI
will be scheduled so that the patient can combine a visit to the hospital for
clinical and study purposes.
Only in patients who have negative regular imaging and positive DW-MRI , the
diagnostic protocol will differ from the regular protocol. They will undergo
endoscopy with taking of a biopsy as they normally would not. These patients
might benefit if conventional imaging is false-negative and DW-MRI is
true-positive (since studies on DW-MRI reported higher sensitivity and
specificity than conventional imaging). However, the DW-MRI might also be
false-postive. In that case, the patient undergoes unnecessary endoscopy with
taking of a biopsy with risks such as infection, bleeding and the risk of
general anaesthesia. However, these are very rare complications.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients with clinical suspicion of local recurrence after treated for laryngeal- hypopharyngeal- or oropharyngeal squamous cell carcinoma with (chemo)radiation.
Primary (chemo)radiation for the primary tumour region
Last radiotherapy: > 2 months and < 3 years
*Informed consent* signed by patient
Age * 18 years
Exclusion criteria
Patient with contraindication of MRI or contrast agent as defined in the protocols of the radiology department of the UMCU
Patients with primary salvage surgery for the primary lesion
Patients whom recurrence is obvious that no additional imaging confirmation is necessary for the decision to take biopsies.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL37889.041.11 |
OMON | NL-OMON29514 |