Determine if additional pre-operative MRI decreases the incidence of irradical lumpectomies, changes surgical planning for BCT, reduces the incidence of re-operations, increases sensitivity and/or specificity, and is cost-effective.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
diagnostisch onderzoek met als doel tot een optimale planning voor borstsparende chirurgie te komen voor patiënten met mammacarcinoom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of irradical lumpectomies
The primary goal of additional preoperative imaging and discussion is to reduce
the rate of irradical lumpectomies. The histology reports of the specimen will
be the reference standard. Assessment of irradicallity will be judged according
to national guidelines. The percentage of lumpectomy specimens with positive
margins will be documented and compared to that in the historical control
group.
Secondary outcome
- Reduction of re-operations
The number and percentage of re-operations will be documented and compared to
that in the historical control group.
- Accuracy of tumor size estimation
Histology reports of the specimens of all patients will be compared with the
outcomes of clinical examination and breast imaging with and without MRI in
order to assess extent of tumor and size in mm*s. Correlation coefficients
versus histology (as reference standard) will be calculated for the sizes
determined by conventional workup and by MRI.
- Sensitivity and specificity of the imaging modalities in diagnosing tumor
size and extent
Histology (as reference standard) of the specimens of all patients will be
compared with the outcomes of breast imaging with and without MRI in order to
assess sensitivity and specificity of the imaging modalities, and especially
MRI, in diagnosing size and extent of the tumor.
- Cost-effectiveness of preoperative MRI
Finally, a cost-effectiveness analysis of preoperative MRI will be performed,
taking into account the costs of clinical examination, the preoperative imaging
procedures, the costs of the initial surgical procedures and re-operations, and
the effectiveness of radical versus irradical treatment.
Background summary
Breast conservation therapy (BCT) is an appropriate and cosmetically preferable
alternative to mastectomy for early-stage invasive breast cancers as well as
ductal carcinoma in situ (DCIS). BCT requires complete removal of all tumor,
necessitating histologically negative margins to decrease the risk of local
recurrence. In case of close or positive margins re-excision or mastectomy will
be performed to achieve a radical excision. Therefore, patients eligible for
breast conserving therapy may require more than one operation.
Accurate preoperative assessment of tumor size and disease extent is essential
for surgical planning. Clinical examination, mammography and ultrasound are the
standard techniques to assess tumor extent. However, clinical examination
correlates poorly with histology; mammography tends to underestimate tumor size
and focality; and ultrasound is limited in the detection of multifocality and
ductal carcinoma in situ (DCIS). Magnetic Resonance Imaging (MRI) has a high
sensitivity, correlates well with histology, and gives an accurate estimate of
tumor size and focality in most cases. We propose that preoperative MRI of the
breast will provide surgeons with more accurate information about tumor size
and position, resulting in a lower percentage of positive margins and thus of
re-operation.
Study objective
Determine if additional pre-operative MRI decreases the incidence of irradical
lumpectomies, changes surgical planning for BCT, reduces the incidence of
re-operations, increases sensitivity and/or specificity, and is cost-effective.
Study design
Historically-controlled cohort study.
Study burden and risks
Subjects will undergo a single MRI scan, with contrast, in addition to the
normal pre-operative work-up. MRI of the breast is a non-invasive, safe
technique with little patient discomfort. If indicated an extra ultrasound
examination will be performed, with biopsy if necessary. The subjects will
benefit from a more thorough diagnostic work-up and more informed surgical
planning than they would receive without participation. This trial should
result in information to improve the quality of the diagnostic work-up of BCT
patients as well as being a vessel for the implementation of a new and better
diagnostic work-up, if this is warranted.
's-Gravendijkwal 230
3015 CE
Nederland
's-Gravendijkwal 230
3015 CE
Nederland
Listed location countries
Age
Inclusion criteria
- breast cancer patients eligible for breast conserving therapy
- signed informed consent
Exclusion criteria
- contra-indications for MRI
- pregnancy
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 | NL15262.078.06 |