Molecular Imaging and Spectroscopy With Stable Isotopes in Oncology and Neurology (MISSION-ovary)

May 4, 2018 updated by: Surrin Deen, Cambridge University Hospitals NHS Foundation Trust

A Physiological Study of the Metabolism of Pyruvate in High Grade Serous Ovarian Cancer Using Hyperpolarised Carbon-13 Magnetic Resonance Spectroscopic Imaging

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Please Select An Option Below
      • Cambridge, Please Select An Option Below, United Kingdom, CB2 0QQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with ovarian cancer

Description

Inclusion Criteria:

  • To be included in this study the patient must:

    1. Be 18 years or older.
    2. Have a confirmed or likely diagnosis of HGSOC, breast cancer, prostate cancer, pancreatic mass, liver mass, renal mass or brain tumour.
    3. Be aware of their diagnosis.
    4. Be a likely surgical candidate who is fit for possible surgery.
    5. Have no contraindications to the use of the IV contrast agents involved in this study.
    6. Be able to provide written informed consent according to ICH/GCP, national and local regulations.
    7. Volunteers of childbearing potential must have a negative pregnancy test, either urinary or blood prior to enrolment.
    8. Have ECOG performance status 0 or 1.
    9. Express willingness and ability to comply with scheduled visits, laboratory tests, imaging and other study procedures.

Exclusion Criteria:

  • The presence of any of the following will preclude the patient from the study:

    1. Any disorder that may adversely affect levels of pyruvate or lactate such as diabetes mellitus.
    2. The use of medications that may affect levels of pyruvate or lactate such as metformin or insulin.
    3. Known allergy or adverse reaction to any of the injected contrast agents proposed for use in this study.
    4. Pregnancy or breastfeeding.
    5. 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.
    6. Laboratory abnormalities that may have an unknown or unpredictable impact on study results.
    7. Not suitable for MR scanning e.g. severe obesity, inability to lie still or contraindicated metal implants such as the intrauterine contraceptive device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ovarian cancer patients
MRI and FDG-PET imaging
Diagnostic test: MRI scan and FDG-PET scan
Scanning with MRI and FDG-PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging of the metabolism of hyperpolarized 13C-pyruvate in ovarian cancer tissue to hyperpolarized 13C-lactate.
Time Frame: 1 July 2016 to 31 December 2018
Imaging of the metabolism of hyperpolarized 13C-pyruvate in ovarian cancer tissue to hyperpolarized 13C-lactate.
1 July 2016 to 31 December 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the hyperpolarized 13C images from tumour with histological, biochemical and genetic information gained after surgery and/or biopsy.
Time Frame: 1 July 2016 to 31 December 2018
Correlation of the hyperpolarized 13C images from tumour with histological, biochemical and genetic information gained after surgery and/or biopsy.
1 July 2016 to 31 December 2018
Detection of the change in the metabolism of hyperpolarized 13C-pyruvate following systemic anticancer therapy.
Time Frame: 1 July 2016 to 31 December 2018
Detection of the change in the metabolism of hyperpolarized 13C-pyruvate following systemic anticancer therapy.
1 July 2016 to 31 December 2018

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine if the metabolism of hyperpolarized 13C-pyruvate can be detected in a small number of patients with breast cancer, prostate cancer, pancreatic masses, liver masses, renal masses and brain tumours
Time Frame: 1 July 2016 to 31 December 2018
To determine if the metabolism of hyperpolarized 13C-pyruvate can be detected in a small number of patients with breast cancer, prostate cancer, pancreatic masses, liver masses, renal masses and brain tumours
1 July 2016 to 31 December 2018
To investigate the relationship between hyperpolarized 13C-pyruvate MRSI and 18F-FDG uptake on PET.
Time Frame: 1 July 2016 to 31 December 2018
To investigate the relationship between hyperpolarized 13C-pyruvate MRSI and 18F-FDG uptake on PET.
1 July 2016 to 31 December 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A093768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Consent has been obtained to share imaging results with other researchers working in similar imaging however there are no definite plans to do this unless results require verification from other sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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