Diagnostic Accuracy of MRI, DWI MRI, FDG-PET/CT and FEC PET/CT in the Detection of Lymph Node Metastases in Surgically Staged Endometrial and Cervical Carcinoma

NCT01836484 | Completed DMC

• 1 other identifier: 007697
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 7

Brief Summary

This is a prospective diagnostic performance study which compares three new imaging methods with the current standard imaging method for the diagnosis of metastatic lymph nodes.

Conditions

Surgically Staged Endometrial and Cervical Carcinoma; Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher; Endometrial Cancer; Stage 1A With Myometrial Invasion or Any Higher Stage and Grade 3; Stage 1A With Myometrial Invasion or Any Other Higher Stage and Serous Papillary or Clear Cell Sub-types; Stage II Disease or Above and Any Histology Grade

Keywords

Surgically staged endometrial carcinoma; Surgically staged cervical carcinoma

Outcome Measures

Primary Outcomes (1)

• Detection rate (DR) vrs false positive rate (FPR) for each of the diagnostic modalities.

  36 months

Secondary Outcomes (3)

• Detection rate (DR) vrs false positive rate (FPR) between each of the diagnostic modalities and within different histological sub-sets.

  36 months

• Nodal Coverage planning: standard radiotherapy planning vrs DW-MRI

  36 months

• Histopathological findings vrs functional imaging findings

  36 months

Study Arms (1)

Surgically staged endometrial and cervical carcinoma

Diagnostic Test: Diffusion-weighted MRI; Diagnostic Test: Fluorodeoxyglucose-18-PET/CT; Diagnostic Test: Fluoro-ethyl-coline-PET/CT

Interventions

Diffusion-weighted MRI DIAGNOSTIC_TEST

Also known as: DW-MRI

Surgically staged endometrial and cervical carcinoma

Fluorodeoxyglucose-18-PET/CT DIAGNOSTIC_TEST

Also known as: FDG-PET/CT

Surgically staged endometrial and cervical carcinoma

Fluoro-ethyl-coline-PET/CT DIAGNOSTIC_TEST

Also known as: FEC-PET/CT

Surgically staged endometrial and cervical carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 women with histologically confirmed endometrial or cervical carcinoma.

You may qualify if:

• Females 18 years or older; (no upper limit).
• Patients with histologically confirmed cancer of the cervix or endometrium.
• In patient with cervix cancer, there must be confirmation of invasive disease; FIGO stage 1B1 or higher FIGO stage demonstrated clinically and/or on MRI. In patients with advanced disease being considered for chemoradiotherapy treatment, patients may be considered for entry if nodal lymphadenectomy is being used to inform radiotherapy planning;
• In patients with endometrial cancer, a) stage 1A with myometrial invasion or any higher stage and grade 3 b) stage 1A with myometrial invasion or any other higher stage and serous papillary or clear cell sub-types
• stage II disease or above and any histology grade The MDT decision may be based on the combination of tumour characteristics on histology, clinical and imaging findings.
• No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI.
• Fit for surgical lymphadenectomy, as determined by the local MDT. The patient should also be considered fit for extended field radiotherapy in cases where lymphadenectomy is being undertaken to inform radiotherapy planning.
• The extent of lymph node dissection will be made by the local multidisciplinary team, based on the presence of risk factors for lymph node metastases, according to the protocol. Patients must be considered fit to undergo lymph node dissection.
• Able and willing to give written informed consent and to comply with the study protocol procedures

You may not qualify if:

• Known contra-indication to MRI or PET/CT scan.
• Known allergy to FDG or FEC.
• Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT.
• If the patient is pregnant or breast-feeding.
• Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control) from the time consent is signed until 6 weeks after the last PET/CT scan unless undergoing hysterectomy.
• Note: subjects are not considered of childbearing potential if they are surgically sterile (they have undergone bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal
• Females of childbearing potential must have a negative pregnancy test within three weeks prior to being registered for the study.
• Participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP). If patient's have recently completed a CTIMP trial they must have had their last dose(s) of study drug prior to their first imaging procedure on the MAPPING study.
• Participation in another clinical trial (CTIMP or non-CTIMP) where the protocol contains imaging procedures that would occur during the MAPPING study.
• Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Birmingham Women's NHS Foundation Trust: collaborator
• Case Western Reserve University: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Hammersmith Hospitals NHS Trust: collaborator
• Memorial Sloan-Kettering Cancer Center, USA: collaborator
• Queen Elizabeth Hospital, Gateshead, UK: collaborator
• Royal Preston Hospital, Lancashire, UK: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• University of Birmingham: collaborator

Study Sites (7)

Queen Elizabeth Hospital, Birmingham University Hospitals, Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

Birmingham City Hospital, Sandwell & West Birmingham Hospitals NHS Trust

Birmingham, B18 7QH, United Kingdom

Location

St Bartholomew's Hospital, Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

University College London Hospital

London, NW1 2BU, United Kingdom

Location

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust

Preston, PR2 9HT, United Kingdom

Location

The Royal Marsden, The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Lymph node tissue samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Lymphoma, Follicular; Disease

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Andrea Rockall, Professor

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: April 22, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

GB (7)