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Status unknownNCT03526809MISSION-ovaryUpdated May 16, 2018

Molecular Imaging and Spectroscopy With Stable Isotopes in Oncology and Neurology

An observational study in Ovarian Cancer, sponsored by Cambridge University Hospitals NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-05-16.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 99 Years
Sex
Female
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Study 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.

Read the 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.
02

Conditions studied

  • Ovarian Cancer

Keywords

  • Magnetic resonance imaging
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 40 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with ovarian cancer

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ovarian cancer patients

    MRI and FDG-PET imaging

    Diagnostic Test: MRI scan and FDG-PET scan

Interventions

  • Diagnostic testMRI scan and FDG-PET scan

    Scanning with MRI and FDG-PET

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 July 2016 to 31 December 2018

Secondary outcomes

  1. 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.

    Time frame: 1 July 2016 to 31 December 2018

  2. 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.

    Time frame: 1 July 2016 to 31 December 2018

Other outcomes

  1. 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

    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

  2. To investigate the relationship between hyperpolarized 13C-pyruvate MRSI and 18F-FDG uptake on PET.

    To investigate the relationship between hyperpolarized 13C-pyruvate MRSI and 18F-FDG uptake on PET.

    Time frame: 1 July 2016 to 31 December 2018

07

Study locations

1 of 1 sites recruiting
  • Addenbrooke's Hospital
    Cambridge, Please Select An Option Below CB2 0QQ, United Kingdom
    Recruiting
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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03526809
Lead sponsor
Cambridge University Hospitals NHS Foundation Trust
Responsible party
Surrin Deen (Honorary Clinical Fellow, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
May 16, 2018
Start date
Jun 1, 2016
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
May 16, 2018

Study contacts

Ferdia Gallagher
Contact
fag1000@cam.ac.uk
01223336890
Surrin Deen
Contact
surrindeen@hotmail.com
07758800872

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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