Pathologic validation of tumour volume, location, and microscopic extension on 7 Tesla MR images using whole mount histopathology.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of 7 Tesla MRI in determining the residual tumour volume,
location, and extension after neoadjuvant radiotherapy. Location is determined
by comparison of the center of the tumour on 7T images and in whole mount
pathology. The tumour extension is defined as the distance between the outline
of the tumour in pathology and the tumour outline on imaging.
Secondary outcome
Define the most optimal 7T sequences in determining tumour volume, validated
with pathology;.
If available, a comparison of tumour volume as determined on 7T and 3T images
will be made.
Background summary
Radical surgery following chemoradiation is effective in achieving disease
control in patients with locally advanced stage rectal cancer, but associated
with substantial morbidity. After chemoradiation, 15-20% of patients don*t show
residual tumour cells at postoperative histological examination. In these
pathological complete responders, surgery might be safely omitted. However,
preoperative identification of patients with a pathological complete response
(pCR) is challenging due to misinterpretation of radiation induced changes as
tumour and missing of microscopic residual tumour. Use of ultra-high field 7
Tesla MRI may improve the diagnostic accuracy of identifying a complete
response following chemoradiation.
Study objective
Pathologic validation of tumour volume, location, and microscopic extension on
7 Tesla MR images using whole mount histopathology.
Study design
A pathology validation study of MR imaging in 10 patients with rectal cancer,
nested within a prospective colorectal cancer cohort (PLCRC). Patients undergo
7 Tesla MRI prior to surgery. Rectal specimens are subjected to whole mount
pathologic examination, in which the entire specimen is examined, allowing for
accurate spatial correlation with MR images.
Study burden and risks
The patient risk and burden associated with this study is minimal. Study
participation possibly requires one extra hospital visit to undergo 7 Tesla MRI
prior to surgery. After rectal cancer surgery, the surgical specimen including
the tumour will be imaged ex vivo using 7 Tesla MRI. Because of the extensive
histopathological procedure (whole mount examination), the pathological
diagnosis may be delayed by several days. This will not interfere with adjuvant
treatment. There is no individual benefit.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
* Informed consent for PLCRC;
* Informed consent for the use of clinical data
* Informed consent for future studies within PLCRC;
* Eligible for neoadjuvant radiotherapy;
* Eligible for rectal surgery by Total Mesorectal Excision (either Low Anterior Resection, Abdominoperineal Resection or Hartmann resection).
Exclusion criteria
* Patients with distant metastasis requiring surgery between chemoradiation and rectal surgery;
* MRI contraindications according to the MR safety protocol of the imaging division of the UMC Utrecht.
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 | NL60928.041.17 |