Molecular Imaging and Spectroscopy With Stable Isotopes in Oncology and Neurology (NCT03526809) | Clinical Trial Compass
UnknownNot Applicable
Molecular Imaging and Spectroscopy With Stable Isotopes in Oncology and Neurology
United Kingdom40 participantsStarted 2016-06-01
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexFEMALE
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Inclusion criteria
✓. Be 18 years or older.
✓. Have a confirmed or likely diagnosis of HGSOC, breast cancer, prostate cancer, pancreatic mass, liver mass, renal mass or brain tumour.
✓. Be aware of their diagnosis.
✓. Be a likely surgical candidate who is fit for possible surgery.
✓. Have no contraindications to the use of the IV contrast agents involved in this study.
✓. Be able to provide written informed consent according to ICH/GCP, national and local regulations.
✓. Volunteers of childbearing potential must have a negative pregnancy test, either urinary or blood prior to enrolment.
✓. Have ECOG performance status 0 or 1.
Exclusion criteria
✕. Any disorder that may adversely affect levels of pyruvate or lactate such as diabetes mellitus.
✕. The use of medications that may affect levels of pyruvate or lactate such as metformin or insulin.
✕. Known allergy or adverse reaction to any of the injected contrast agents proposed for use in this study.
✕. Pregnancy or breastfeeding.
✕. Other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or in the judgement of the investigators make it undesirable for the patient to enter the study.
What they're measuring
1
Imaging of the metabolism of hyperpolarized 13C-pyruvate in ovarian cancer tissue to hyperpolarized 13C-lactate.
Timeframe: 1 July 2016 to 31 December 2018
Trial details
NCT IDNCT03526809
SponsorCambridge University Hospitals NHS Foundation Trust
✕. Laboratory abnormalities that may have an unknown or unpredictable impact on study results.
✕. Not suitable for MR scanning e.g. severe obesity, inability to lie still or contraindicated metal implants such as the intrauterine contraceptive device.