Clinical trial NCT01505829: Diffusion-weighted Imaging Study in Cancer of the Ovary
Official title: Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Peritoneal Metastases
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: Royal Marsden NHS Foundation Trust
name: Cambridge University Hospitals NHS Foundation Trust
name: Imperial College Healthcare NHS Trust
name: Northumbria Healthcare NHS Foundation Trust
name: East and North Hertfordshire NHS Trust
First posted: 2012-01-09
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary or relapsed ovarian cancer

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response.
timeFrame: 4.0 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
city: Newcastle
country: United Kingdom
facility: Queen Elizabeth Hospital
state: Gateshead
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
city: Sutton
country: United Kingdom
facility: The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
state: Surrey
city: Swansea
country: United Kingdom
facility: Singleton Hospital
state: Wales
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: ICR
name: Nandita deSouza, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.