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Clinical Trial Summary

Patients with known ovarian cancer will be imaged up to four times with FDG-PET, C13 MRI and other novel MRI techniques during their treatment course including: before the start of any treatment (with optional repeat scanning), after the first dose of chemotherapy (optional), after the third dose of chemotherapy (optional) and after surgery (optional). Imaging findings will be compared to biological properties of cancer tissue samples.


Clinical Trial Description

This is a single-centre prospective physiological study.

1. Participants will be recruited through MDTs and clinics.

2. Baseline screening blood tests will be performed.

3. Baseline MRI will be undertaken to identify lesions to be studied. This will be followed by hyperpolarised carbon-13 MRSI after the injection of hyperpolarised 13C-pyruvate. Scanning with 18F-FDG PET in combination with CT or MRI may optionally be performed in the same imaging visit.

4. A subset of patients (up to 10) will undergo repeat hyperpolarised carbon-13 MRSI within 5 days of baseline imaging to assess for reproducibility of the imaging test.

5. Where possible, image-guided biopsy will be performed to obtain tissue from selected lesions for analysis.

6. During the first month of and later during systemic anticancer therapy, MRI and carbon-13 MRSI will be again carried out to assess to look for changes in pyruvate metabolism. If possible, a further biopsy will be undertaken at this stage. Scanning with 18F-FDG PET in combination with CT or MRI may optionally be performed in the same imaging visit.

7. MRI and carbon-13 MRSI will be carried out after the full course of systemic anticancer therapy, to assess for treatment response and to identify lesions in preparation for tissue extraction at surgery. Scanning with 18F-FDG PET in combination with CT or MRI may optionally be performed in the same imaging visit.

8. During surgery, tissue samples will be collected either by excision or biopsy.

9. MRI may be performed after surgery in selected patients.

10. In up to 10 participants, carbon-13 MRSI will be done 3 to 6 weeks after surgery to look for areas of pyruvate or lactate accumulation that may correlate with long term prognosis. Only participants who are not part of the subset undergoing retest carbon-13 MRSI to assess for reproducibility will be invited for post-surgical carbon-13 MRSI, this is to keep the number of carbon-13 MRSI scans each participant has at a maximum of four in order to minimise inconvenience to participants caused by having to make repeat visits for imaging.

11. Participants will be followed up for one year in the clinic and/or through their GP. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03526809
Study type Observational
Source Cambridge University Hospitals NHS Foundation Trust
Contact Ferdia Gallagher
Phone 01223336890
Email fag1000@cam.ac.uk
Status Recruiting
Phase
Start date June 1, 2016
Completion date December 31, 2019

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