MAPPING

Phase 1

• Conditions: Endometrial and Cervical Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001290-78-GB
• Lead Sponsor: Barts Health NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-05
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1.Females older than 18 years; (no upper limit).
2.Patients with histologically confirmed cancer of the cervix or endometrium.
a.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;
b.In patients with endometrial cancer, a) stage 1A with myometrial invasion or any higher stage and grade 3 histology with lymphovascular space invasion, b) stage 1A with myometrial invasion or any other higher stage and mixed mullerian, serous papillary or clear cell sub-types.
c.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.
3.No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI.
4.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.
5.Able and willing to give written informed consent and to comply with the study protocol procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Known contra-indication to MRI or PET/CT scan.
2.Known allergy to FDG or FEC.
3.Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT.
4.If the patient is pregnant or breast-feeding.
5.Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after the last PET/CT scan.
5.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
6.Females of childbearing potential must have a negative pregnancy test prior to being registered for the study.
7.Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified