Ovarian CancerMISSION-ovaryNCT03526809
Molecular Imaging and Spectroscopy With Stable Isotopes in Oncology and Neurology
An observational study of Ovarian Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- MRI scan and FDG-PET scan
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2016to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ovarian cancer
Who may be able to join
- To be included in this study the patient must:
- 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.
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- 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.
- Express willingness and ability to comply with scheduled visits, laboratory tests, imaging and other study procedures.
Who cannot join
- The presence of any of the following will preclude the patient from the study:
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Please Select An Option Below, CB2 0QQ
Ferdia Gallagher, 01223336890, fag1000@cam.ac.uk
Surrin Deen, 07758800872, surrindeen@hotmail.com
About this study
Official title: 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.
Read the detailed description
This is a single-centre prospective physiological study.
- Participants will be recruited through MDTs and clinics.
- Baseline screening blood tests will be performed.
- 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.
- 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.
- Where possible, image-guided biopsy will be performed to obtain tissue from selected lesions for analysis.
- 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.
- 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.
- During surgery, tissue samples will be collected either by excision or biopsy.
- MRI may be performed after surgery in selected patients.
- 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.
- Participants will be followed up for one year in the clinic and/or through their GP.
- Conditions
- Ovarian Cancer
- Being tested
- MRI scan and FDG-PET scan
- Keywords
- Magnetic resonance imaging
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scan and FDG-PET scanDiagnostic test
Scanning with MRI and FDG-PET
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients | MRI and FDG-PET imaging Receives: Diagnostic Test: MRI scan and FDG-PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging of the metabolism of hyperpolarized 13C-pyruvate in ovarian cancer tissue to hyperpolarized 13C-lactate.
Imaging of the metabolism of hyperpolarized 13C-pyruvate in ovarian cancer tissue to hyperpolarized 13C-lactate.
Measured: 1 July 2016 to 31 December 2018
Secondary outcomes (2)
Correlation of the hyperpolarized 13C images from tumour with histological, biochemical and genetic information gained after surgery and/or biopsy.
Correlation of the hyperpolarized 13C images from tumour with histological, biochemical and genetic information gained after surgery and/or biopsy.
Measured: 1 July 2016 to 31 December 2018
Detection of the change in the metabolism of hyperpolarized 13C-pyruvate following systemic anticancer therapy.
Detection of the change in the metabolism of hyperpolarized 13C-pyruvate following systemic anticancer therapy.
Measured: 1 July 2016 to 31 December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Jun 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surrin Deen, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526809
- Sponsor's protocol ID
- A093768
- Acronym
- MISSION-ovary
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 16 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Study of the Metabolism of Pyruvate in High Grade Serous Ovarian Cancer Using Hyperpolarised Carbon-13 Magnetic Resonance Spectroscopic Imaging
- ClinicalTrials.gov ID
- NCT03526809
- Acronym / sponsor ID
- MISSION-ovary / A093768
- Conditions
- Ovarian Cancer
- Keywords
- Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-centre prospective physiological study.
- Participants will be recruited through MDTs and clinics.
- Baseline screening blood tests will be performed.
- 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.
- 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.
- Where possible, image-guided biopsy will be performed to obtain tissue from selected lesions for analysis.
- 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.
- 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.
- During surgery, tissue samples will be collected either by excision or biopsy.
- MRI may be performed after surgery in selected patients.
- 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.
- Participants will be followed up for one year in the clinic and/or through their GP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | – | Diagnostic Test: MRI scan and FDG-PET scanMRI and FDG-PET imaging |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ovarian cancer
Key inclusion criteria (10 listed)
- To be included in this study the patient must:
Key exclusion criteria (8 listed)
- The presence of any of the following will preclude the patient from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scan and FDG-PET scanScanning with MRI and FDG-PET | Diagnostic test | Ovarian cancer patients |
Primary outcome
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.
2 secondary outcomes
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
Detection of the change in the metabolism of hyperpolarized 13C-pyruvate following systemic anticancer therapy.
Time frame: 1 July 2016 to 31 December 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferdia Gallagher (01223336890, fag1000@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.