Cervix CancerNCT00126841
Computed Tomotherapy (CT) and Magnetic Resonance Imaging (MRI) Fusion on Radiation Treatment Planning for Patients With Cancer of the Cervix
An observational study of Cervix Cancer, run by Alberta Health services at 1 site in Canada.
Trial summary
Patients with more advanced stages of cervix cancer are treated by radiotherapy. Overall, more than 50% are cured. Approximately half of those patients not cured have current cancer in the irradiated volume. Higher doses of radiation would be expected to cure more patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- CT and MR fusion
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2004to Nov 2005
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Cervical cancer undergoing primary radiotherapy
Who cannot join
- Stage 1B
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess the Feasibility and Impact of Computed Tomotherapy (CT) and Magnetic Resonance Imaging (MRI) Fusion on Radiation Treatment Planning for Ten Patients With Cancer of the Cervix
Patients with more advanced stages of cervix cancer are treated by radiotherapy. Overall, more than 50% are cured. Approximately half of those patients not cured have current cancer in the irradiated volume. Higher doses of radiation would be expected to cure more patients. To give high doses of radiation safely, the investigators need to know very precisely where the cancer is and then they can use new technology available at the Cross Cancer Institute (tomotherapy) to target the cancer precisely, giving higher doses to the cancerous tissues and lower doses to the non-cancerous tissues.
This study of ten patients with cervical cancer will investigate the added value of MRI scanning on precise tumor definition to facilitate more accurate radiotherapy treatment planning. For this study, patients will be treated in the conventional way with conventional doses. The investigators hope that treatment for future patients will be planned with MRI data and that they will be treated to higher doses of tomotherapy.
Read the detailed description
Rationale/Background:
For a long time diagnostic imaging has been used in planning radiation treatment for the carcinoma of the cervix, although it is not the essential part of FIGO staging work up. In the past, treatment planning was based on examination under anesthesia (EUA) findings and standard portals were used. Various studies have shown high risks of geographical miss and/or inappropriate tumor coverage (up to >70%) with the use of standard portals, which was related to poor local control. Increasingly, diagnostic/planning CT and MRI imaging are used to plan radiation treatment.
Most patients with invasive carcinoma of the cervix, who are not candidates for radical hysterectomy, are treated by radiotherapy, often with concomitant chemotherapy with a curative intent. Amongst those patients, where cure is not achieved, there are a significant proportion who fail first or only in the pelvis. Higher doses of radiation would be expected to reduce this risk. With conventional radiotherapy, higher doses of radiation result in a higher rate of complications. New technology available at the Cross Cancer Institute (tomotherapy + intensity modulated radiation therapy [IMRT]) would be expected to permit higher doses of radiation to be delivered but avoid the increased risk of complications. Accurate definition of clinical target volume, composed of the cervix, uterus, gross primary tumor and the regional lymphatic drainage is required for accurate treatment planning. The MRI imaging is expected to be valuable in this regard. Demonstrating this is the immediate aim of this study. The investigators' long term aim will be to replace conventional external beam radiotherapy with helical tomotherapy. They expect to be able to apply increasing doses of radiation to the GTV + CTV and monitor short-term treatment effects with biological imaging, principally magnetic resonance spectroscopy (MRS). Eventually the investigators hope to be able to individualize radiation doses based in part on biological imaging, before and during treatment.
In their center the investigators routinely perform diagnostic and planning CT scans of almost all Ca. cervix patients before radiation treatment planning. This study will involve one additional MRI scan of the pelvis, which will take about 30 minutes to perform; this process has potential benefit in the treatment planning.
Studies comparing imaging modalities for diagnostic accuracy:
There are studies in which CT and MRI scans were performed preoperatively and results were compared with surgical-pathological outcome to confirm their diagnostic accuracy in terms of tumor detection, parametrial invasion, lymph node status and adjacent organ involvement. MRI was consistently reported to be more accurate than CT scan in terms of tumor delineation and normal organ localization. This is also true for a meta-analysis of 17 eligible studies.
Studies Comparing Imaging Modalities for Treatment Planning:
Not surprisingly CT planning was shown to be superior over standard field technique for external beam radiation therapy (EBRT) and brachytherapy planning for ca cervix patients. There was less chance of geographical miss by using an imaging modality for planning. Studies comparing MRI and CT for treatment planning showed that MRI led to significant changes in field borders.
Image Fusion:
Harms W et al from Germany studied the fusion of CT and MRI images from sixteen patients who were treated by interstitial (n=12) and endocavitary (n=4) brachytherapy for recurrent cervix, head and neck, sarcoma and vulva carcinoma. They compared conventional 3D-brachytherapy planning based on CT-information alone to brachytherapy planning based on fused CT and MRI data. They measured the accuracy of image fusion using predefined corresponding landmarks in the CT and MRI data. They found that an automated algorithm was robust and reliable (mean registration error 1.8 mm, range 0.8-4.1 mm, SD 0.9 mm); tumor visualization was difficult using CT alone; and brachytherapy treatment planning based on fused CT and MRI data enabled better definition of target volume and critical structures as compared to treatment planning based on CT alone.
Patients and Methods:
Ten patients with a histological diagnosis of cervix carcinoma who are to receive treatment at the Cross Cancer Institute will be enrolled in this fusion study. They will go through the usual investigations prior to treatment planning, including CT imaging. In addition, patients will have an MRI of the pelvis which takes approximately about 30 minutes.
CT and MRI imaging will be fused using fusion software. Treatment planning for standard four field box technique and tomotherapy will be done on CT images as usual and subsequently on fused images. Tumor coverage and normal organ doses will be recorded and compared. Tumor control probabilities and normal tissue complication probabilities will be calculated for the different plans to facilitate objective comparisons.
Conclusion:
Most patients with invasive carcinoma of the cervix, who are not candidates for a radical hysterectomy, are often treated by concomitant chemo-radiation with a curative intent. Patients who cannot achieve a cure with this treatment fail first or only in the pelvis. The higher doses of radiation would be expected to reduce this risk, which cannot be achieved with conventional radiotherapy due to higher rates of complications. Tomotherapy based treatment planning would be expected to obtain higher doses of radiation to be delivered but avoid the measured risk of complications. More accurate definition of clinical target volume, composed of the cervix, uterus, gross primary tumor and the regional lymphatic drainage is required for accurate treatment planning. Currently the investigators are planning on the basis of CT scan only in their center; MRI scan is consistently shown to be superior over CT for treatment. Fusing MRI and CT images are expected to delineate structures more accurately compared to CT alone and therefore will be valuable in accurate treatment planning to deliver higher doses to CTV without increasing treatment related complications.
Objectives:
- To assess the feasibility of image fusion between MRI and CT for radiotherapy (RT) planning in Ca. Cervix
- To determine the added value of fused MRI and CT over CT alone for RT planning.
- Conditions
- Cervix Cancer
- Being tested
- CT and MR fusion
- Keywords
- radiotherapy planning CT/MR fusion
- 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.
CT and MR fusionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startNov 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervix 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Robert Pearcey, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126841
- Sponsor's protocol ID
- GY-03-0019
- Status last verified
- Dec 2011
- First submitted
- 3 Aug 2005
- Last updated
- 9 Dec 2011
- Results posted
- No
Publications
Subak LL, Hricak H, Powell CB, Azizi L, Stern JL. Cervical carcinoma: computed tomography and magnetic resonance imaging for preoperative staging. Obstet Gynecol. 1995 Jul;86(1):43-50. doi: 10.1016/0029-7844(95)00109-5.
PubMed 7784021Ozsarlak O, Tjalma W, Schepens E, Corthouts B, Op de Beeck B, Van Marck E, Parizel PM, De Schepper AM. The correlation of preoperative CT, MR imaging, and clinical staging (FIGO) with histopathology findings in primary cervical carcinoma. Eur Radiol. 2003 Oct;13(10):2338-45. doi: 10.1007/s00330-003-1928-2. Epub 2003 Jun 12.
PubMed 12802611Kim SH, Choi BI, Han JK, Kim HD, Lee HP, Kang SB, Lee JY, Han MC. Preoperative staging of uterine cervical carcinoma: comparison of CT and MRI in 99 patients. J Comput Assist Tomogr. 1993 Jul-Aug;17(4):633-40. doi: 10.1097/00004728-199307000-00022.
PubMed 8331236Ho CM, Chien TY, Jeng CM, Tsang YM, Shih BY, Chang SC. Staging of cervical cancer: comparison between magnetic resonance imaging, computed tomography and pelvic examination under anesthesia. J Formos Med Assoc. 1992 Oct;91(10):982-90.
PubMed 1362678Bipat S, Glas AS, van der Velden J, Zwinderman AH, Bossuyt PM, Stoker J. Computed tomography and magnetic resonance imaging in staging of uterine cervical carcinoma: a systematic review. Gynecol Oncol. 2003 Oct;91(1):59-66. doi: 10.1016/s0090-8258(03)00409-8.
PubMed 14529663Scheidler J, Hricak H, Yu KK, Subak L, Segal MR. Radiological evaluation of lymph node metastases in patients with cervical cancer. A meta-analysis. JAMA. 1997 Oct 1;278(13):1096-101.
PubMed 9315770Knocke TH, Pokrajac B, Fellner C, Potter R. [A comparison of CT-supported 3D planning with simulator planning in the pelvic irradiation of primary cervical carcinoma]. Strahlenther Onkol. 1999 Feb;175(2):68-73. doi: 10.1007/BF02753845. German.
PubMed 10065141Wachter-Gerstner N, Wachter S, Reinstadler E, Fellner C, Knocke TH, Potter R. The impact of sectional imaging on dose escalation in endocavitary HDR-brachytherapy of cervical cancer: results of a prospective comparative trial. Radiother Oncol. 2003 Jul;68(1):51-9. doi: 10.1016/s0167-8140(03)00083-5.
PubMed 12885452Krempien RC, Daeuber S, Hensley FW, Wannenmacher M, Harms W. Image fusion of CT and MRI data enables improved target volume definition in 3D-brachytherapy treatment planning. Brachytherapy. 2003;2(3):164-71. doi: 10.1016/S1538-4721(03)00133-8.
PubMed 15062139
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Feasibility and Impact of Computed Tomotherapy (CT) and Magnetic Resonance Imaging (MRI) Fusion on Radiation Treatment Planning for Ten Patients With Cancer of the Cervix
- ClinicalTrials.gov ID
- NCT00126841
- Acronym / sponsor ID
- GY-03-0019
- Conditions
- Cervix Cancer
- Keywords
- radiotherapy planning CT/MR fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Nov 2005
- First posted
- 5 Aug 2005 (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.
Patients with more advanced stages of cervix cancer are treated by radiotherapy. Overall, more than 50% are cured. Approximately half of those patients not cured have current cancer in the irradiated volume. Higher doses of radiation would be expected to cure more patients. To give high doses of radiation safely, the investigators need to know very precisely where the cancer is and then they can use new technology available at the Cross Cancer Institute (tomotherapy) to target the cancer precisely, giving higher doses to the cancerous tissues and lower doses to the non-cancerous tissues.
This study of ten patients with cervical cancer will investigate the added value of MRI scanning on precise tumor definition to facilitate more accurate radiotherapy treatment planning. For this study, patients will be treated in the conventional way with conventional doses. The investigators hope that treatment for future patients will be planned with MRI data and that they will be treated to higher doses of tomotherapy.
Detailed description
Rationale/Background:
For a long time diagnostic imaging has been used in planning radiation treatment for the carcinoma of the cervix, although it is not the essential part of FIGO staging work up. In the past, treatment planning was based on examination under anesthesia (EUA) findings and standard portals were used. Various studies have shown high risks of geographical miss and/or inappropriate tumor coverage (up to >70%) with the use of standard portals, which was related to poor local control. Increasingly, diagnostic/planning CT and MRI imaging are used to plan radiation treatment.
Most patients with invasive carcinoma of the cervix, who are not candidates for radical hysterectomy, are treated by radiotherapy, often with concomitant chemotherapy with a curative intent. Amongst those patients, where cure is not achieved, there are a significant proportion who fail first or only in the pelvis. Higher doses of radiation would be expected to reduce this risk. With conventional radiotherapy, higher doses of radiation result in a higher rate of complications. New technology available at the Cross Cancer Institute (tomotherapy + intensity modulated radiation therapy [IMRT]) would be expected to permit higher doses of radiation to be delivered but avoid the increased risk of complications. Accurate definition of clinical target volume, composed of the cervix, uterus, gross primary tumor and the regional lymphatic drainage is required for accurate treatment planning. The MRI imaging is expected to be valuable in this regard. Demonstrating this is the immediate aim of this study. The investigators' long term aim will be to replace conventional external beam radiotherapy with helical tomotherapy. They expect to be able to apply increasing doses of radiation to the GTV + CTV and monitor short-term treatment effects with biological imaging, principally magnetic resonance spectroscopy (MRS). Eventually the investigators hope to be able to individualize radiation doses based in part on biological imaging, before and during treatment.
In their center the investigators routinely perform diagnostic and planning CT scans of almost all Ca. cervix patients before radiation treatment planning. This study will involve one additional MRI scan of the pelvis, which will take about 30 minutes to perform; this process has potential benefit in the treatment planning.
Studies comparing imaging modalities for diagnostic accuracy:
There are studies in which CT and MRI scans were performed preoperatively and results were compared with surgical-pathological outcome to confirm their diagnostic accuracy in terms of tumor detection, parametrial invasion, lymph node status and adjacent organ involvement. MRI was consistently reported to be more accurate than CT scan in terms of tumor delineation and normal organ localization. This is also true for a meta-analysis of 17 eligible studies.
Studies Comparing Imaging Modalities for Treatment Planning:
Not surprisingly CT planning was shown to be superior over standard field technique for external beam radiation therapy (EBRT) and brachytherapy planning for ca cervix patients. There was less chance of geographical miss by using an imaging modality for planning. Studies comparing MRI and CT for treatment planning showed that MRI led to significant changes in field borders.
Image Fusion:
Harms W et al from Germany studied the fusion of CT and MRI images from sixteen patients who were treated by interstitial (n=12) and endocavitary (n=4) brachytherapy for recurrent cervix, head and neck, sarcoma and vulva carcinoma. They compared conventional 3D-brachytherapy planning based on CT-information alone to brachytherapy planning based on fused CT and MRI data. They measured the accuracy of image fusion using predefined corresponding landmarks in the CT and MRI data. They found that an automated algorithm was robust and reliable (mean registration error 1.8 mm, range 0.8-4.1 mm, SD 0.9 mm); tumor visualization was difficult using CT alone; and brachytherapy treatment planning based on fused CT and MRI data enabled better definition of target volume and critical structures as compared to treatment planning based on CT alone.
Patients and Methods:
Ten patients with a histological diagnosis of cervix carcinoma who are to receive treatment at the Cross Cancer Institute will be enrolled in this fusion study. They will go through the usual investigations prior to treatment planning, including CT imaging. In addition, patients will have an MRI of the pelvis which takes approximately about 30 minutes.
CT and MRI imaging will be fused using fusion software. Treatment planning for standard four field box technique and tomotherapy will be done on CT images as usual and subsequently on fused images. Tumor coverage and normal organ doses will be recorded and compared. Tumor control probabilities and normal tissue complication probabilities will be calculated for the different plans to facilitate objective comparisons.
Conclusion:
Most patients with invasive carcinoma of the cervix, who are not candidates for a radical hysterectomy, are often treated by concomitant chemo-radiation with a curative intent. Patients who cannot achieve a cure with this treatment fail first or only in the pelvis. The higher doses of radiation would be expected to reduce this risk, which cannot be achieved with conventional radiotherapy due to higher rates of complications. Tomotherapy based treatment planning would be expected to obtain higher doses of radiation to be delivered but avoid the measured risk of complications. More accurate definition of clinical target volume, composed of the cervix, uterus, gross primary tumor and the regional lymphatic drainage is required for accurate treatment planning. Currently the investigators are planning on the basis of CT scan only in their center; MRI scan is consistently shown to be superior over CT for treatment. Fusing MRI and CT images are expected to delineate structures more accurately compared to CT alone and therefore will be valuable in accurate treatment planning to deliver higher doses to CTV without increasing treatment related complications.
Objectives:
- To assess the feasibility of image fusion between MRI and CT for radiotherapy (RT) planning in Ca. Cervix
- To determine the added value of fused MRI and CT over CT alone for RT planning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Cervical cancer undergoing primary radiotherapy
Key exclusion criteria (2 listed)
- Stage 1B
- Patient refusal
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 |
|---|---|---|
| CT and MR fusion | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 9 Dec 2011.
- Background: PubMed 7784021Subak LL, Hricak H, Powell CB, Azizi L, Stern JL. Cervical carcinoma: computed tomography and magnetic resonance imaging for preoperative staging. Obstet Gynecol. 1995 Jul;86(1):43-50. doi: 10.1016/0029-7844(95)00109-5.
- Background: PubMed 12802611Ozsarlak O, Tjalma W, Schepens E, Corthouts B, Op de Beeck B, Van Marck E, Parizel PM, De Schepper AM. The correlation of preoperative CT, MR imaging, and clinical staging (FIGO) with histopathology findings in primary cervical carcinoma. Eur Radiol. 2003 Oct;13(10):2338-45. doi: 10.1007/s00330-003-1928-2. Epub 2003 Jun 12.
- Background: PubMed 8331236Kim SH, Choi BI, Han JK, Kim HD, Lee HP, Kang SB, Lee JY, Han MC. Preoperative staging of uterine cervical carcinoma: comparison of CT and MRI in 99 patients. J Comput Assist Tomogr. 1993 Jul-Aug;17(4):633-40. doi: 10.1097/00004728-199307000-00022.
- Background: PubMed 1362678Ho CM, Chien TY, Jeng CM, Tsang YM, Shih BY, Chang SC. Staging of cervical cancer: comparison between magnetic resonance imaging, computed tomography and pelvic examination under anesthesia. J Formos Med Assoc. 1992 Oct;91(10):982-90.
- Background: PubMed 14529663Bipat S, Glas AS, van der Velden J, Zwinderman AH, Bossuyt PM, Stoker J. Computed tomography and magnetic resonance imaging in staging of uterine cervical carcinoma: a systematic review. Gynecol Oncol. 2003 Oct;91(1):59-66. doi: 10.1016/s0090-8258(03)00409-8.
- Background: PubMed 9315770Scheidler J, Hricak H, Yu KK, Subak L, Segal MR. Radiological evaluation of lymph node metastases in patients with cervical cancer. A meta-analysis. JAMA. 1997 Oct 1;278(13):1096-101.
- Background: PubMed 10065141Knocke TH, Pokrajac B, Fellner C, Potter R. [A comparison of CT-supported 3D planning with simulator planning in the pelvic irradiation of primary cervical carcinoma]. Strahlenther Onkol. 1999 Feb;175(2):68-73. doi: 10.1007/BF02753845. German.
- Background: PubMed 12885452Wachter-Gerstner N, Wachter S, Reinstadler E, Fellner C, Knocke TH, Potter R. The impact of sectional imaging on dose escalation in endocavitary HDR-brachytherapy of cervical cancer: results of a prospective comparative trial. Radiother Oncol. 2003 Jul;68(1):51-9. doi: 10.1016/s0167-8140(03)00083-5.
- Background: PubMed 15062139Krempien RC, Daeuber S, Hensley FW, Wannenmacher M, Harms W. Image fusion of CT and MRI data enables improved target volume definition in 3D-brachytherapy treatment planning. Brachytherapy. 2003;2(3):164-71. doi: 10.1016/S1538-4721(03)00133-8.
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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.
Robert Pearcey, MD principal investigator
AHS Cancer Control Alberta
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 Cervix Cancer, run by Alberta Health services 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 1 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: finished, as of the sponsor's last update on 9 Dec 2011. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00126841, which also lists 9 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 9 Dec 2011.