Uterine Cervical NeoplasmsIMAPNCT01989364
Repetitive Functional Imaging in Locally Advanced Cervical Cancer
An observational study of Uterine Cervical Neoplasms, run by Aarhus University Hospital at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- How many people
- 50 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2011to Jan 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced cervical cancer eligible for chemo-radiotherapy
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospitals Leuven
Leuven, 3000
Karin Haustermans, Prof., 16 3 46902 ext. +32, karin.haustermans@med.kuleuven.be
Karin Haustermans, Prof.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Jacob C. Lindegaard, M.D., 78462577 ext. +45, jacolind@rm.dk
Jesper F. Kallehauge, Ph.D., jespkall@rm.dk
Netherlands1 site, 1 recruiting
- Not yet recruiting
The Netherlands Cancer Institute
Amsterdam, 1066 CX
Uulke v.d. Heide, Ph.D., 20 512 2350 ext. + 31 (0), u.vd.heide@nki.nl
Uulke v.d. Heide, Ph.D:
About this study
Official title: Multicenter Validation of Repetitive Functional Imaging in Locally Advanced Cervical Cancer
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.
Read more
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.
- Conditions
- Uterine Cervical Neoplasms
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor volume
Measured: pre-treatment, week2, week5, week6, week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionFeb 2016 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Kallehauge, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989364
- Sponsor's protocol ID
- M-20100251
- Acronym
- IMAP
- Status last verified
- Nov 2013
- First submitted
- 15 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation of Repetitive Functional Imaging in Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT01989364
- Acronym / sponsor ID
- IMAP / M-20100251
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Universitaire Ziekenhuizen KU Leuven
- Study start
- Jan 2011
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced cervical cancer eligible for chemo-radiotherapy
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor volume
Time frame: pre-treatment, week2, week5, week6, week 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Aarhus University Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor volume (time frame: pre-treatment, week2, week5, week6, week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.