Cervical CancerNCT01710085
Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients
A study testing Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011 in people with Cervical Cancer and Endometrial Cancer, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- What is being tested?
- Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2012to Feb 2014
- 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
- Pathologic diagnosis of cervical or endometrial cancer.
- Patients treated with curative surgery (hysterectomy)will be involved on a voluntary basis.
Who cannot join
- Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear implants, claustrophobic patients)
Trial locations and contacts
1 site in 1 country.
Gürsel Savcı contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludağ Üniversitesi
Bursa
Kadir Hacıkurt, +905055873273, hacikurt@uludag.edu.tr
Kadir Hacıkurt
About this study
Official title: Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery
Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new technique recently started to be performed in body imaging and has potential ability to detect recurrent disease. The aim of this study is to investigate the diagnostic impact of DWI in detection of recurrent disease in patients treated with curative surgery in endometrial and cervical cancer.
Read the detailed description
Endometrial and cervical cancers are one of the most common malignancies seen in female genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment options depending on the stage.
Identification of recurrent disease in early phases carries a primary importance on the prognosis.
Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body imaging has potential ability to distinguish recurrent disease from normal tissue or fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
All patients who had curative surgery due to endometrial or cervical cancer will be included to the study. Patients will be examined with DWI in addition to routine sequences including contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive and negative predictive values of the study will be investigated from the data derived from DWI studies and will be correlated with data obtained by conventional radiologic, nuclear imaging studies including PET-CT, as well as pathologic verifications during follow-up period.
- Conditions
- Cervical Cancer, Endometrial Cancer
- Being tested
- Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011
- Keywords
- Diffusion weighted MRI, Curative surgery, Recurrence
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011Device
Recurrence in cervical and endometrial cancer patients who were treated with curative surgery is routinely investigated by MRI examination. MRI is diagnostic technique not requiring ionizing radiation and is based on magnetic fields.
| Study group | Role | What they receive |
|---|---|---|
| Diffusion weighted imaging, Recurrence | Experimental | Not described Receives: Device: Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Hacikurt, Uludag University
- Investigators
- Gürsel Savcı, Prof., Study director, Uludag UniversityKadir Hacıkurt, Dr., Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710085
- Sponsor's protocol ID
- KUAP(T)-2012/39
- Status last verified
- Oct 2012
- First submitted
- 11 Oct 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery
- ClinicalTrials.gov ID
- NCT01710085
- Acronym / sponsor ID
- KUAP(T)-2012/39
- Conditions
- Cervical Cancer, Endometrial Cancer
- Keywords
- Diffusion weighted MRI, Curative surgery, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 18 Oct 2012 (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.
Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new technique recently started to be performed in body imaging and has potential ability to detect recurrent disease. The aim of this study is to investigate the diagnostic impact of DWI in detection of recurrent disease in patients treated with curative surgery in endometrial and cervical cancer.
Detailed description
Endometrial and cervical cancers are one of the most common malignancies seen in female genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment options depending on the stage.
Identification of recurrent disease in early phases carries a primary importance on the prognosis.
Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body imaging has potential ability to distinguish recurrent disease from normal tissue or fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
All patients who had curative surgery due to endometrial or cervical cancer will be included to the study. Patients will be examined with DWI in addition to routine sequences including contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive and negative predictive values of the study will be investigated from the data derived from DWI studies and will be correlated with data obtained by conventional radiologic, nuclear imaging studies including PET-CT, as well as pathologic verifications during follow-up period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion weighted imaging, Recurrence | Experimental | Device: Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologic diagnosis of cervical or endometrial cancer.
- Patients treated with curative surgery (hysterectomy)will be involved on a voluntary basis.
Key exclusion criteria (1 listed)
- Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear implants, claustrophobic patients)
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 |
|---|---|---|
| Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011Recurrence in cervical and endometrial cancer patients who were treated with curative surgery is routinely investigated by MRI examination. MRI is diagnostic technique not requiring ionizing radiation and is based on magnetic fields. | Device | Diffusion weighted imaging, Recurrence |
Primary outcome
Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Time frame: 18 months
Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Gürsel Savcı contact
Gürsel Savcı, Prof. study director
Uludag University
Kadir Hacıkurt, Dr. principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011 in people with Cervical Cancer and Endometrial Cancer, run by Uludag University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 18 Oct 2012. 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 Turkey (Türkiye). 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?
Contact Kadir Hacıkurt (+905055873273, hacikurt@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer. (time frame: 18 months). 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 18 Oct 2012.