Diffusion-weighted Imaging Study in Cancer of the Ovary

NCT ID: NCT01505829

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-10-13

Brief Summary

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This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.

Detailed Description

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Conditions

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Ovarian Cancer Peritoneal Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Biological validation cohort 1

No interventions assigned to this group

Response assessment cohort 2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage III or IV
* Scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery.

Exclusion Criteria

* Life expectancy of less than 6 months
* MRI contraindications
* Low grade or heavily calcified disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Northumbria Healthcare NHS Foundation Trust

OTHER

Sponsor Role collaborator

East and North Hertfordshire NHS Trust

OTHER_GOV

Sponsor Role collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role lead

Responsible Party

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Nandita deSouza

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nandita deSouza, Professor

Role: PRINCIPAL_INVESTIGATOR

ICR

Locations

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Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status

Queen Elizabeth Hospital

Newcastle, Gateshead, United Kingdom

Site Status

Mount Vernon Cancer Centre

Northwood, Middlesex, United Kingdom

Site Status

The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status

Singleton Hospital

Swansea, Wales, United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Winfield JM, Wakefield JC, Brenton JD, AbdulJabbar K, Savio A, Freeman S, Pace E, Lutchman-Singh K, Vroobel KM, Yuan Y, Banerjee S, Porta N, Ahmed Raza SE, deSouza NM. Biomarkers for site-specific response to neoadjuvant chemotherapy in epithelial ovarian cancer: relating MRI changes to tumour cell load and necrosis. Br J Cancer. 2021 Mar;124(6):1130-1137. doi: 10.1038/s41416-020-01217-5. Epub 2021 Jan 4.

Reference Type DERIVED
PMID: 33398064 (View on PubMed)

Other Identifiers

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C1353/A12762

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11/LO/1598 CCR3694

Identifier Type: -

Identifier Source: org_study_id

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