Cervical Cancer Squamous CellNCT01899404
MRI FDG PET Imaging Cervix
A study testing 18-FDG PET/CT, DWI, DCE-MRI in people with Cervical Cancer Squamous Cell, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer Squamous Cell
- What is being tested?
- 18-FDG PET/CT, DWI, DCE-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2012to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
- FIGO Stage IB - IVA
- Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
- Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
- No cytotoxic anti-cancer therapy for cervix cancer prior to study entry
- A negative urine or serum pregnancy test within the two week interval immediately prior to the first PET-CT imaging, in women of child-bearing age
- Ability to provide written informed consent to participate in the study
Who cannot join
- Prior complete or partial hysterectomy
- Carcinoma of the cervical stump
- Inability to lie supine for more than 30 minutes
- Insulin-dependent diabetes mellitus
- Impaired kidney function with glomerular filtration rate < 30
- Previous anaphylactic reaction to gadolinium or other contraindications to MR.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, The Princess Margaret
Toronto, Ontario, M5G 2M9
About this study
Official title: A Pilot Prospective Study of the Utility of Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted MRI (DWI)and Positron Emission Tomography (PET) Imaging With 18F-Fluorodeoxyglucose (18FDG) in Brachytherapy for Cervix Cancer
The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.
The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:
- special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
- an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.
- Conditions
- Cervical Cancer Squamous Cell
- Being tested
- 18-FDG PET/CT, DWI, DCE-MRI
- Keywords
- Cervical Cancer, PET Scan for cervix, MRI for cervix
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-FDG PET/CT, DWI, DCE-MRIBiological
All patients on this study will receive a Diffuse Weighted MRI and Dynamic Contrast Enhancing MRI during the routine MRI session on the day of brachytherapy (additional 10 minutes), and a FDG PET/CT scanning session on the day of brachytherapy.
| Study group | Role | What they receive |
|---|---|---|
| 18-FDG PET/CT, DWI, DCE-MRI | Experimental | Not described Receives: Biological: 18-FDG PET/CT, DWI, DCE-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer
Measured: 2 years
Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.
This objective will evaluate the potential for translation of this technique to centres with limited MRI access.
Measured: 2 years
Secondary outcomes (2)
Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy
Measured: 2 years
Imaging techniques for visualizing the brachytherapy applicator.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study start3 Oct 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer Squamous CellStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Kathy Han, MD, Principal investigator, University Health Network, The Princess Margaret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899404
- Sponsor's protocol ID
- UHN REB 12-5221-C
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2012
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Study of the Utility of Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI), Diffusion Weighted MRI (DWI)and Positron Emission Tomography (PET) Imaging With 18F-Fluorodeoxyglucose (18FDG) in Brachytherapy for Cervix Cancer
- ClinicalTrials.gov ID
- NCT01899404
- Acronym / sponsor ID
- UHN REB 12-5221-C
- Conditions
- Cervical Cancer Squamous Cell
- Keywords
- Cervical Cancer, PET Scan for cervix, MRI for cervix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 3 Oct 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jul 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.
The standard treatment for cervix cancer at Princess Margaret Hospital is external radiation with chemotherapy followed by internal radiation, called brachytherapy. Currently, brachytherapy treatment is planned on a type of Magnetic Resonance Imaging (MRI) called T2-weighted (T2W) MRI.
The main purpose of this study is to determine whether the following imaging tests can visualize the tumor better for planning the brachytherapy treatment:
- special types of MRI called diffusion weighted MRI (DWI) and dynamic-contrast enhanced MRI (DCE-MRI); and
- an x-ray test called positron emission test (PET) performed with a sugar dye called FDG. MRI-guided brachytherapy is resource-intensive and not widely available.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-FDG PET/CT, DWI, DCE-MRI | Experimental | Biological: 18-FDG PET/CT, DWI, DCE-MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix
- FIGO Stage IB - IVA
- Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group
- Intention to treat with MR-guided brachytherapy as part of standard radiotherapy according to the current treatment policies of the PMH Gynecology Group
Key exclusion criteria (6 listed)
- Prior complete or partial hysterectomy
- Carcinoma of the cervical stump
- Inability to lie supine for more than 30 minutes
- Insulin-dependent diabetes mellitus
- Impaired kidney function with glomerular filtration rate < 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-FDG PET/CT, DWI, DCE-MRIAll patients on this study will receive a Diffuse Weighted MRI and Dynamic Contrast Enhancing MRI during the routine MRI session on the day of brachytherapy (additional 10 minutes), and a FDG PET/CT scanning session on the day of brachytherapy. | Biological | 18-FDG PET/CT, DWI, DCE-MRI |
Primary outcome
Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer
Time frame: 2 years
Target delineation using standard MRI acquired during the last week of EBRT fused to planning CT versus full MRI-guided brachytherapy.
Time frame: 2 years
This objective will evaluate the potential for translation of this technique to centres with limited MRI access.
2 secondary outcomes
Follow-up imaging (MRI and 18FDG PET) versus the imaging done at the time of brachytherapy
Time frame: 2 years
Imaging techniques for visualizing the brachytherapy applicator.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
Kathy Han, MD principal investigator
University Health Network, The Princess Margaret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18-FDG PET/CT, DWI, DCE-MRI in people with Cervical Cancer Squamous Cell, run by University Health Network, Toronto at 1 site in Canada.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target delineation in brachytherapy using standard T2-weighted MRI versus DCE-MRI, DWI and FDG-PET/CT imaging: gross tumor volume and high-risk clinical target volume in patients with cervical cancer (time frame: 2 years). The study lists 2 primary outcomes in all. 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 8 Nov 2022.