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

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ClinicalTrials.gov Identifier: NCT03526809
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Surrin Deen, Cambridge University Hospitals NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment
Ovarian Cancer Diagnostic Test: MRI scan and FDG-PET scan

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
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Physiological Study of the Metabolism of Pyruvate in High Grade Serous Ovarian Cancer Using Hyperpolarised Carbon-13 Magnetic Resonance Spectroscopic Imaging
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  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 [ 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

  2. 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.


Biospecimen Retention:   Samples With DNA
Fixed and frozen ovarian cancer specimens from areas imaged collected by image guided biopsy and surgery.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patient with ovarian cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ovarian cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526809


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

Locations
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, Please Select An Option Below, United Kingdom, CB2 0QQ
Contact: Ferdia Gallagher    01223336890    fag1000@cam.ac.uk   
Contact: Surrin Deen    07758800872    surrindeen@hotmail.com   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust

Responsible Party: Surrin Deen, Honorary Clinical Fellow, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03526809     History of Changes
Other Study ID Numbers: A093768
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Surrin Deen, Cambridge University Hospitals NHS Foundation Trust:
Magnetic resonance imaging

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders