NeoplasmsIQ-EMBRACENCT03210428
Quantitative MR Imaging in Locally Advanced Cervical Cancer
An observational study of Neoplasms and Functional Magnetic Resonance Imaging, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Hypoxic tumour cells within the primary tumour have shown prognostic importance for local and metastatic disease control in several cancer sites. 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Functional Magnetic Resonance Imaging, Radiotherapy
- How many people
- 320 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Oct 2018to Sep 2023
- 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
- Adult, Older adult
Study population: Yearly, each EMBRACE II centre is expected to enrol 10-20 patients. The inclusion for the imaging protocol in a given centre is expected to be 70% of patients enrolled in EMBRACE II. We expect that at least 8 institutions will enrol 10 patients per year, which will result in minimum 80 patients per year, and thereby at least 320 patients within the 4-year study period. This number is sufficient to meet the required number of patients for the hypotheses in the overall patient population (sample size 196 patients) and in the high-risk patients (sample size 248 patients )
Who may be able to join
- Patients included in the EMBRACE study (see inclusion criteria in the EMBRACE protocol)
- Patients without previous record of allergic reaction to infusion of protocol related contrast media (Gadolinium-based)
- Patients with sufficient kidney function according to local regulations
- Patient informed consent
Who cannot join
- According to EMBRACE II protocol
- Patients with active infection or severe medical condition
Trial locations and contacts
1 site in 1 country.
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
About this study
Official title: Quantitative MR Imaging in Locally Advanced Cervical Cancer Sub-study Under the EMBRACE II Protocol
Hypoxic tumour cells within the primary tumour have shown prognostic importance for local and metastatic disease control in several cancer sites. 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. DCE MR imaging has been used to quantify the extent of poor perfusion regions within cervical tumours and it has been shown to be a surrogate of hypoxia. Furthermore, a number of studies have demonstrated that DCE MR is predictive of disease failure in cervix cancer.
The EMBRACE II study will implement an imaging sub-study, which will evaluate the value of quantitative MR imaging to identify patients at increased risk of disease recurrence (local, nodal and systemic).
Read the detailed description
Radiotherapy is an important treatment modality in the management of cancers of the uterine cervix. About half of patients with cervical cancer receive definitive radiotherapy in the course of their disease. Radiotherapy is most often administered as a combination of external beam radiotherapy (EBRT) and brachytherapy (BT). In the late 90's a major breakthrough in cervical cancer radiotherapy took place with the introduction of MR image guidance of BT. By performing MR imaging before each BT implant it is possible adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of organs at risk (bladder, rectum and sigmoid) but also the tumour regression induced by the preceding EBRT and chemotherapy.
Functional imaging that reflects hypoxia, metabolism, heamodynamics and tissue structure have been applied to locally advanced cervical cancer with the goal to identify imaging markers that may predict outcome early on and improve tissue classification. DCE-MRI may be the most investigated so far for locally advanced cervical cancer. A comprehensive literature review including papers investigating the prognostic value of DCE-MRI in patients with locally advanced cervical cancer identified 20 papers from 10 research groups, with a median number of 30 patients (range 7-102 patients). A total number of 17 papers publish a positive association between pre-treatment DCE-MRI and outcome in terms of local control or disease free survival (1-17). However, not all studies present independent cohorts of patients. Three papers show no effect (18-20) The studies on cervical cancer points in the direction that DCE-MRI has the capability to identify aggressive forms of cervical cancer, and that the pre-treatment measurements may serve as, predictive markers for outcome after chemo-radiotherapy. The largest studies indicate that in particular the tumour fraction with the lowest signal enhancement is an important parameter, though the diversity in methodology is significant.
Diffusion weighted MRI (DWI-MRI) has to a lesser extent than DCE-MRI been investigated in locally advanced cervical cancer. Most studies using DWI-MRI in cervical cancer have investigated its diagnostic capabilities (21-28) all concluding high sensitivity and specificity (review by Kundu et al. (29)). The Toronto group; McVeight et al. (26) and later Gladwish et al. (30) found prior to the onset of treatment that the highest 90th % ADC value correlated with response, similar finding was found by the group in Tianjin; Liu et al. (22). Both groups found that higher ADC value insides the tumour was predictive of poor response to treatment and suggest the higher ADC to be connected to tumour necrosis. When tumour necrosis, occur there is loss of cell membrane integrity and therefore an increase in the extracellular volume and a decrease in intracellular volume effectively increasing the ADC. Conversely, the group from London UK; Harry et al. (31) and Somoye et al. (32) showed no correlation to treatment response at the time prior to treatment. Instead the ADC at 2 weeks (and the change in ADC) into treatment was predictive of treatment response and prognostic of patient outcome. Finally, Marconi et al. (33) found a relation between minimum ADC in the tumor and both DSS and DFS.
This is an observational prospective, non-randomized study in which patients with locally advanced cervical cancer included in the EMBRACE II study can enroll. The study will be carried out in 8-15 EMBRACE centres. MRI will be carried out prior to radiotherapy. The details of the MRI exams will differ from standard clinical practice in the centres, but will be consistent with international guidelines for cervix MRI. The exam will include T1, T2, diffusion, and dynamic contrast-enhanced imaging. At time of brachytherapy, the treatment planning MRI will additionally include DWI and qT2. Patients will be followed up according to the EMBRACE II follow-up schedule.
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control measure
To evaluate the sensitivity and specificity of dynamic contrast enhanced (DCE-MRI) to identify patients who have increased risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer
Measured: 5 years
Secondary outcomes (1)
Radiomics
To apply radiomics for identification of patients who have increased risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer. Radiomics analysis will include features from DCE-MRI, DWI and quantitative T2 imaging
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start18 Oct 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Principal investigator, Jesper Kallehauge, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210428
- Sponsor's protocol ID
- 57480
- Acronym
- IQ-EMBRACE
- Status last verified
- Feb 2020
- First submitted
- 3 Jul 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mayr NA, Huang Z, Wang JZ, Lo SS, Fan JM, Grecula JC, Sammet S, Sammet CL, Jia G, Zhang J, Knopp MV, Yuh WT. Characterizing tumor heterogeneity with functional imaging and quantifying high-risk tumor volume for early prediction of treatment outcome: cervical cancer as a model. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):972-9. doi: 10.1016/j.ijrobp.2011.08.011. Epub 2011 Dec 28.
PubMed 22208967Mayr NA, Wang JZ, Zhang D, Grecula JC, Lo SS, Jaroura D, Montebello J, Zhang H, Li K, Lu L, Huang Z, Fowler JM, Wu DH, Knopp MV, Yuh WT. Longitudinal changes in tumor perfusion pattern during the radiation therapy course and its clinical impact in cervical cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):502-8. doi: 10.1016/j.ijrobp.2009.04.084. Epub 2009 Sep 21.
PubMed 19775824Andersen EK, Hole KH, Lund KV, Sundfor K, Kristensen GB, Lyng H, Malinen E. Dynamic contrast-enhanced MRI of cervical cancers: temporal percentile screening of contrast enhancement identifies parameters for prediction of chemoradioresistance. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e485-92. doi: 10.1016/j.ijrobp.2011.05.050. Epub 2011 Oct 17.
PubMed 22014954Loncaster JA, Carrington BM, Sykes JR, Jones AP, Todd SM, Cooper R, Buckley DL, Davidson SE, Logue JP, Hunter RD, West CM. Prediction of radiotherapy outcome using dynamic contrast enhanced MRI of carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):759-67. doi: 10.1016/s0360-3016(02)02972-3.
PubMed 12377328Takayama Y, Ohno T, Kishimoto R, Kato S, Yoneyama R, Kandatsu S, Tsujii H, Obata T. Prediction of early response to radiotherapy of uterine carcinoma with dynamic contrast-enhanced MR imaging using pixel analysis of MR perfusion imaging. Magn Reson Imaging. 2009 Apr;27(3):370-6. doi: 10.1016/j.mri.2008.07.007. Epub 2008 Sep 2.
PubMed 18768283Semple SI, Harry VN, Parkin DE, Gilbert FJ. A combined pharmacokinetic and radiologic assessment of dynamic contrast-enhanced magnetic resonance imaging predicts response to chemoradiation in locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):611-7. doi: 10.1016/j.ijrobp.2009.04.069.
PubMed 19735887Mayr NA, Yuh WT, Zheng J, Ehrhardt JC, Magnotta VA, Sorosky JI, Pelsang RE, Oberley LW, Hussey DH. Prediction of tumor control in patients with cervical cancer: analysis of combined volume and dynamic enhancement pattern by MR imaging. AJR Am J Roentgenol. 1998 Jan;170(1):177-82. doi: 10.2214/ajr.170.1.9423627.
PubMed 9423627Mayr NA, Yuh WT, Magnotta VA, Ehrhardt JC, Wheeler JA, Sorosky JI, Davis CS, Wen BC, Martin DD, Pelsang RE, Buller RE, Oberley LW, Mellenberg DE, Hussey DH. Tumor perfusion studies using fast magnetic resonance imaging technique in advanced cervical cancer: a new noninvasive predictive assay. Int J Radiat Oncol Biol Phys. 1996 Oct 1;36(3):623-33. doi: 10.1016/s0360-3016(97)85090-0.
PubMed 8948347Mayr NA, Yuh WT, Arnholt JC, Ehrhardt JC, Sorosky JI, Magnotta VA, Berbaum KS, Zhen W, Paulino AC, Oberley LW, Sood AK, Buatti JM. Pixel analysis of MR perfusion imaging in predicting radiation therapy outcome in cervical cancer. J Magn Reson Imaging. 2000 Dec;12(6):1027-33. doi: 10.1002/1522-2586(200012)12:63.0.co;2-5.
PubMed 11105046Mannelli L, Patterson AJ, Zahra M, Priest AN, Graves MJ, Lomas DJ, Tan LT, Crawford R, Brenton J, Sala E. Evaluation of nonenhancing tumor fraction assessed by dynamic contrast-enhanced MRI subtraction as a predictor of decrease in tumor volume in response to chemoradiotherapy in advanced cervical cancer. AJR Am J Roentgenol. 2010 Aug;195(2):524-7. doi: 10.2214/AJR.09.3437.
PubMed 20651213Zahra MA, Tan LT, Priest AN, Graves MJ, Arends M, Crawford RA, Brenton JD, Lomas DJ, Sala E. Semiquantitative and quantitative dynamic contrast-enhanced magnetic resonance imaging measurements predict radiation response in cervix cancer. Int J Radiat Oncol Biol Phys. 2009 Jul 1;74(3):766-73. doi: 10.1016/j.ijrobp.2008.08.023. Epub 2008 Nov 18.
PubMed 19019563Gong QY, Brunt JN, Romaniuk CS, Oakley JP, Tan LT, Roberts N, Whitehouse GH, Jones B. Contrast enhanced dynamic MRI of cervical carcinoma during radiotherapy: early prediction of tumour regression rate. Br J Radiol. 1999 Dec;72(864):1177-84. doi: 10.1259/bjr.72.864.10703475.
PubMed 10703475Andersen EK, Kristensen GB, Lyng H, Malinen E. Pharmacokinetic analysis and k-means clustering of DCEMR images for radiotherapy outcome prediction of advanced cervical cancers. Acta Oncol. 2011 Aug;50(6):859-65. doi: 10.3109/0284186X.2011.578586.
PubMed 21767185Mayr NA, Wang JZ, Zhang D, Montebello JF, Grecula JC, Lo SS, Fowler JM, Yuh WT. Synergistic effects of hemoglobin and tumor perfusion on tumor control and survival in cervical cancer. Int J Radiat Oncol Biol Phys. 2009 Aug 1;74(5):1513-21. doi: 10.1016/j.ijrobp.2008.09.050. Epub 2009 Mar 13.
PubMed 19286329Huang Z, Yuh KA, Lo SS, Grecula JC, Sammet S, Sammet CL, Jia G, Knopp MV, Wu Q, Beauchamp NJ 3rd, Yuh WT, Wang R, Mayr NA. Validation of optimal DCE-MRI perfusion threshold to classify at-risk tumor imaging voxels in heterogeneous cervical cancer for outcome prediction. Magn Reson Imaging. 2014 Dec;32(10):1198-205. doi: 10.1016/j.mri.2014.08.039. Epub 2014 Aug 29.
PubMed 25179141
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative MR Imaging in Locally Advanced Cervical Cancer Sub-study Under the EMBRACE II Protocol
- ClinicalTrials.gov ID
- NCT03210428
- Acronym / sponsor ID
- IQ-EMBRACE / 57480
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Jul 2017 (actual)
- 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.
Hypoxic tumour cells within the primary tumour have shown prognostic importance for local and metastatic disease control in several cancer sites. 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. DCE MR imaging has been used to quantify the extent of poor perfusion regions within cervical tumours and it has been shown to be a surrogate of hypoxia. Furthermore, a number of studies have demonstrated that DCE MR is predictive of disease failure in cervix cancer.
The EMBRACE II study will implement an imaging sub-study, which will evaluate the value of quantitative MR imaging to identify patients at increased risk of disease recurrence (local, nodal and systemic).
Detailed description
Radiotherapy is an important treatment modality in the management of cancers of the uterine cervix. About half of patients with cervical cancer receive definitive radiotherapy in the course of their disease. Radiotherapy is most often administered as a combination of external beam radiotherapy (EBRT) and brachytherapy (BT). In the late 90's a major breakthrough in cervical cancer radiotherapy took place with the introduction of MR image guidance of BT. By performing MR imaging before each BT implant it is possible adapt the dose given by BT to the anatomy of each individual patient taking into account not only the position of organs at risk (bladder, rectum and sigmoid) but also the tumour regression induced by the preceding EBRT and chemotherapy.
Functional imaging that reflects hypoxia, metabolism, heamodynamics and tissue structure have been applied to locally advanced cervical cancer with the goal to identify imaging markers that may predict outcome early on and improve tissue classification. DCE-MRI may be the most investigated so far for locally advanced cervical cancer. A comprehensive literature review including papers investigating the prognostic value of DCE-MRI in patients with locally advanced cervical cancer identified 20 papers from 10 research groups, with a median number of 30 patients (range 7-102 patients). A total number of 17 papers publish a positive association between pre-treatment DCE-MRI and outcome in terms of local control or disease free survival (1-17). However, not all studies present independent cohorts of patients. Three papers show no effect (18-20) The studies on cervical cancer points in the direction that DCE-MRI has the capability to identify aggressive forms of cervical cancer, and that the pre-treatment measurements may serve as, predictive markers for outcome after chemo-radiotherapy. The largest studies indicate that in particular the tumour fraction with the lowest signal enhancement is an important parameter, though the diversity in methodology is significant.
Diffusion weighted MRI (DWI-MRI) has to a lesser extent than DCE-MRI been investigated in locally advanced cervical cancer. Most studies using DWI-MRI in cervical cancer have investigated its diagnostic capabilities (21-28) all concluding high sensitivity and specificity (review by Kundu et al. (29)). The Toronto group; McVeight et al. (26) and later Gladwish et al. (30) found prior to the onset of treatment that the highest 90th % ADC value correlated with response, similar finding was found by the group in Tianjin; Liu et al. (22). Both groups found that higher ADC value insides the tumour was predictive of poor response to treatment and suggest the higher ADC to be connected to tumour necrosis. When tumour necrosis, occur there is loss of cell membrane integrity and therefore an increase in the extracellular volume and a decrease in intracellular volume effectively increasing the ADC. Conversely, the group from London UK; Harry et al. (31) and Somoye et al. (32) showed no correlation to treatment response at the time prior to treatment. Instead the ADC at 2 weeks (and the change in ADC) into treatment was predictive of treatment response and prognostic of patient outcome. Finally, Marconi et al. (33) found a relation between minimum ADC in the tumor and both DSS and DFS.
This is an observational prospective, non-randomized study in which patients with locally advanced cervical cancer included in the EMBRACE II study can enroll. The study will be carried out in 8-15 EMBRACE centres. MRI will be carried out prior to radiotherapy. The details of the MRI exams will differ from standard clinical practice in the centres, but will be consistent with international guidelines for cervix MRI. The exam will include T1, T2, diffusion, and dynamic contrast-enhanced imaging. At time of brachytherapy, the treatment planning MRI will additionally include DWI and qT2. Patients will be followed up according to the EMBRACE II follow-up schedule.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Yearly, each EMBRACE II centre is expected to enrol 10-20 patients. The inclusion for the imaging protocol in a given centre is expected to be 70% of patients enrolled in EMBRACE II. We expect that at least 8 institutions will enrol 10 patients per year, which will result in minimum 80 patients per year, and thereby at least 320 patients within the 4-year study period. This number is sufficient to meet the required number of patients for the hypotheses in the overall patient population (sample size 196 patients) and in the high-risk patients (sample size 248 patients )
Key inclusion criteria (4 listed)
- Patients included in the EMBRACE study (see inclusion criteria in the EMBRACE protocol)
- Patients without previous record of allergic reaction to infusion of protocol related contrast media (Gadolinium-based)
- Patients with sufficient kidney function according to local regulations
- Patient informed consent
Key exclusion criteria (2 listed)
- According to EMBRACE II protocol
- Patients with active infection or severe medical condition
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
Disease control measure
Time frame: 5 years
To evaluate the sensitivity and specificity of dynamic contrast enhanced (DCE-MRI) to identify patients who have increased risk of disease recurrence (local, nodal, systemic) after radio-chemotherapy of cervix cancer
1 secondary outcome
Radiomics
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 22208967Mayr NA, Huang Z, Wang JZ, Lo SS, Fan JM, Grecula JC, Sammet S, Sammet CL, Jia G, Zhang J, Knopp MV, Yuh WT. Characterizing tumor heterogeneity with functional imaging and quantifying high-risk tumor volume for early prediction of treatment outcome: cervical cancer as a model. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):972-9. doi: 10.1016/j.ijrobp.2011.08.011. Epub 2011 Dec 28.
- Background: PubMed 19775824Mayr NA, Wang JZ, Zhang D, Grecula JC, Lo SS, Jaroura D, Montebello J, Zhang H, Li K, Lu L, Huang Z, Fowler JM, Wu DH, Knopp MV, Yuh WT. Longitudinal changes in tumor perfusion pattern during the radiation therapy course and its clinical impact in cervical cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):502-8. doi: 10.1016/j.ijrobp.2009.04.084. Epub 2009 Sep 21.
- Background: PubMed 22014954Andersen EK, Hole KH, Lund KV, Sundfor K, Kristensen GB, Lyng H, Malinen E. Dynamic contrast-enhanced MRI of cervical cancers: temporal percentile screening of contrast enhancement identifies parameters for prediction of chemoradioresistance. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e485-92. doi: 10.1016/j.ijrobp.2011.05.050. Epub 2011 Oct 17.
- Background: PubMed 12377328Loncaster JA, Carrington BM, Sykes JR, Jones AP, Todd SM, Cooper R, Buckley DL, Davidson SE, Logue JP, Hunter RD, West CM. Prediction of radiotherapy outcome using dynamic contrast enhanced MRI of carcinoma of the cervix. Int J Radiat Oncol Biol Phys. 2002 Nov 1;54(3):759-67. doi: 10.1016/s0360-3016(02)02972-3.
- Background: PubMed 18768283Takayama Y, Ohno T, Kishimoto R, Kato S, Yoneyama R, Kandatsu S, Tsujii H, Obata T. Prediction of early response to radiotherapy of uterine carcinoma with dynamic contrast-enhanced MR imaging using pixel analysis of MR perfusion imaging. Magn Reson Imaging. 2009 Apr;27(3):370-6. doi: 10.1016/j.mri.2008.07.007. Epub 2008 Sep 2.
- Background: PubMed 19735887Semple SI, Harry VN, Parkin DE, Gilbert FJ. A combined pharmacokinetic and radiologic assessment of dynamic contrast-enhanced magnetic resonance imaging predicts response to chemoradiation in locally advanced cervical cancer. Int J Radiat Oncol Biol Phys. 2009 Oct 1;75(2):611-7. doi: 10.1016/j.ijrobp.2009.04.069.
- Background: PubMed 9423627Mayr NA, Yuh WT, Zheng J, Ehrhardt JC, Magnotta VA, Sorosky JI, Pelsang RE, Oberley LW, Hussey DH. Prediction of tumor control in patients with cervical cancer: analysis of combined volume and dynamic enhancement pattern by MR imaging. AJR Am J Roentgenol. 1998 Jan;170(1):177-82. doi: 10.2214/ajr.170.1.9423627.
- Background: PubMed 8948347Mayr NA, Yuh WT, Magnotta VA, Ehrhardt JC, Wheeler JA, Sorosky JI, Davis CS, Wen BC, Martin DD, Pelsang RE, Buller RE, Oberley LW, Mellenberg DE, Hussey DH. Tumor perfusion studies using fast magnetic resonance imaging technique in advanced cervical cancer: a new noninvasive predictive assay. Int J Radiat Oncol Biol Phys. 1996 Oct 1;36(3):623-33. doi: 10.1016/s0360-3016(97)85090-0.
- Background: PubMed 11105046Mayr NA, Yuh WT, Arnholt JC, Ehrhardt JC, Sorosky JI, Magnotta VA, Berbaum KS, Zhen W, Paulino AC, Oberley LW, Sood AK, Buatti JM. Pixel analysis of MR perfusion imaging in predicting radiation therapy outcome in cervical cancer. J Magn Reson Imaging. 2000 Dec;12(6):1027-33. doi: 10.1002/1522-2586(200012)12:63.0.co;2-5.
- Background: PubMed 20651213Mannelli L, Patterson AJ, Zahra M, Priest AN, Graves MJ, Lomas DJ, Tan LT, Crawford R, Brenton J, Sala E. Evaluation of nonenhancing tumor fraction assessed by dynamic contrast-enhanced MRI subtraction as a predictor of decrease in tumor volume in response to chemoradiotherapy in advanced cervical cancer. AJR Am J Roentgenol. 2010 Aug;195(2):524-7. doi: 10.2214/AJR.09.3437.
- Background: PubMed 19019563Zahra MA, Tan LT, Priest AN, Graves MJ, Arends M, Crawford RA, Brenton JD, Lomas DJ, Sala E. Semiquantitative and quantitative dynamic contrast-enhanced magnetic resonance imaging measurements predict radiation response in cervix cancer. Int J Radiat Oncol Biol Phys. 2009 Jul 1;74(3):766-73. doi: 10.1016/j.ijrobp.2008.08.023. Epub 2008 Nov 18.
- Background: PubMed 10703475Gong QY, Brunt JN, Romaniuk CS, Oakley JP, Tan LT, Roberts N, Whitehouse GH, Jones B. Contrast enhanced dynamic MRI of cervical carcinoma during radiotherapy: early prediction of tumour regression rate. Br J Radiol. 1999 Dec;72(864):1177-84. doi: 10.1259/bjr.72.864.10703475.
- EMBRACE study webpageLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Functional Magnetic Resonance Imaging, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 2 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 17 Feb 2020. 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 Denmark. 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?
Disease control measure (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210428, which also lists 33 linked publications.
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 17 Feb 2020.