NCT01989364

Brief Summary

Background: The Apparent Diffusion Coefficient (ADC) acquired by Diffusion Weighted Imaging (DWI-MR) has been shown to correlate with cellular density. The ADC is indicative of Gross Tumour Volume (GTV), and preliminary data shows that the dynamics of DWI volumes during treatment (shrinkage) as well as dose to DWI volumes has impact on treatment outcome. Hypoxic tumour cells within the primary tumour have been identified to have prognostic importance for local control Tumour hypoxia is caused by insufficiency of the tumour vasculature leading to both chronic diffusion limited and acute flow limited hypoxia. Radioresistant hypoxic cells diminish the rate of local control, and the hypoxia driven increase in metastatic potential of the tumour and lowers the rate of distant disease control. Functional imaging has the potential to visualise radioresistant tumour subvolumes. PET scanning (18F-FAZA) is hypothesized to visualise hypoxic tumour subvolumes, and dynamic contrast enhanced (DCE) MR imaging has been used to quantify the extent of poor perfusion regions within cervical tumours. Objectives: Primary: Sensitivity and specificity of functional imaging (18F-FAZA PET (optional), T1w, T2w, DWI-MRI and DCE-MRI) to identify tumours with good and bad response to radio-chemotherapy Secondary: Determining whether there are differences in bias between centre. The difference in bias will be assessed for the T1 and T2 scans and the Ktrans and ADC maps.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

5.1 years

First QC Date

November 15, 2013

Last Update Submit

November 15, 2013

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Tumor volume

    pre-treatment, week2, week5, week6, week 7

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with locally advanced cervical cancer eligible for chemo-radiotherapy

You may qualify if:

  • Patients with locally advanced cervical cancer FIGO stage IB2-IV referred for definitive radio-chemotherapy.
  • Patients where MR guided brachytherapy is part of standard patient treatment.
  • Patients without previous record of allergic reaction to infusion of protocol related contrast media and tracers (Gadolinium-based for MR-imaging, FAZA (when performed))
  • Patients with sufficient kidney function according to local regulations
  • Patients of 18 years age and over.
  • Cancer of the uterine cervix considered suitable for curative treatment.
  • Positive biopsy showing Squamous cell carcinoma, Adeno cell carcinoma, Adeno Squamous cell carcinoma.
  • Staging according to FIGO and TNM performed
  • MRI pelvis at diagnosis available
  • MRI, CT or PET-CT retroperitoneum and abdomen at diagnosis available
  • MRI pelvis with applicator at Brachytherapy timepoint will be performed
  • Patient informed consent

You may not qualify if:

  • Patients with contra indications to MRI and FAZA-PET (when performed)
  • Patients with active infection or severe medical condition
  • Patients pregnant, lactating or with childbearing potential without adequate contraception.
  • Other primary malignancies
  • Metastatic disease beyond paraaortic region (L1-L2)
  • Previous pelvic radiotherapy
  • Previous total or partial hysterectomy
  • Combination of preoperative radiotherapy with surgery
  • Patients receiving Brachytherapy only
  • Patients receiving External Beam radio therapy only
  • Patients receiving neoadjuvant chemotherapy, hyperthermia or other antineoplastic treatments not approved by the Embrace study committee
  • Contra indications to BT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospitals Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph. D.

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

January 1, 2011

Primary Completion

February 1, 2016

Study Completion

January 1, 2018

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

NL(1)DK(1)BE(1)