Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03129776 |
| Other study ID # |
355-2016 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 13, 2017 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to image tumour lactate in study participants with locally
advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as
measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with
diffusion-weighted MRI and 18FDG-PET (fluorodeoxyglucose-positron emission tomography).
Furthermore, lactate imaging will potentially provide additional and more specific
information regarding the metabolic activity of cervical tumours, thereby identifying regions
of radiation resistance and guiding radiation treatment and brachytherapy.
Description:
Patients with locally advanced cervical cancer can be offered definitive treatment with
radiation therapy with concurrent chemotherapy for curative treatment. Brachytherapy is an
essential part of this treatment, used to deliver high central doses after external beam
radiation. Three-dimensional image-guided brachytherapy (3DIGBT) is gradually becoming the
standard of care in many centres across the world. The use of Magnetic Resonance Imaging
(MRI) or Computerized Tomography (CT) for planning helps ensure adequate coverage of tumours,
minimizing doses to organs at risk. However, standard imaging modalities used in 3DIGBT
typically include T2 and T1 weighted MRI sequences or CT scans and visualizing of the disease
can often be challenging. Furthermore, it can be difficult to differentiate between active
cervical cancer and fibrosis, leading to treatment of larger volumes when there is
uncertainty (Akila contouring study).
High tumour lactate concentration has been linked to poor clinical outcomes in patients with
solid tumours, including cervical cancers treated with radiation therapy [1, 2].
Three-dimensional imaging of tumour lactate in patients with locally advanced cervical
cancers may be useful in identifying regions of radiation resistance and guiding treatment
with chemoradiation and brachytherapy. The objective of this study is to image patients with
locally advanced cervical cancer using hyperpolarized 13C MR imaging to obtain a measure of
lactate levels in cervical tumours. Lactate images and measurements will be correlated with
diffusion-weighted MRI, 18FDG-PET imaging and bioluminescence microscopy (BLI).
Up to ten participants with cervical cancer that are to receive radical treatment with
radiation and possible concurrent cisplatin will be recruited for this study from Sunnybrook
Health Sciences Centre (Sunnybrook). A snap-frozen biopsy of the tumour will be taken at the
first clinic visit. Prior to treatment, baseline diffusion weighted MRI images and 18FDG-PET
scans will be obtained. Hyperpolarized 13C MR imaging will be performed through the injection
of 13C pyruvate and measurements of tumour lactate levels. Lactate levels will be correlated
with measurements from bioluminescence microscopy. The images from hyperpolarized 13C MR
imaging will also be compared to diffusion-weighted MR and 18FDG-PET images.
The purpose of this study is to image tumour lactate in study participants with locally
advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as
measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with
diffusion-weighted MRI and 18FDG-PET. Furthermore, lactate imaging will potentially provide
additional and more specific information regarding the metabolic activity of cervical
tumours, thereby identifying regions of radiation resistance and guiding radiation treatment
and brachytherapy.
