Head and Neck CancerNCT01661062
A Study Using Cone Beam CT for Head and Neck Cancer
A study testing Cone Beam Computed Tomography (CT) Scan in people with Head and Neck Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to produce detailed pictures of structures in the body.) In this study, cone beam CT scans will be obtained before individual radiation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cone Beam Computed Tomography (CT) Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of all ages ≥18, both sexes, and all races will be included in this study. Pregnant females will be excluded. No other special classes of subjects (i.e., prisoners) will be entered.
- Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and neck.
- Patients must be recommended treatment with definitive radiation therapy with concurrent chemotherapy, but without prior surgical resection of the primary tumor or lymph nodes
- Patients must be recommended a treatment course of at least 30 radiation fractions
- Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Hospital indicating that they are aware that undergoing cone beam CT of the head and neck is voluntary and has potential risks.
Who cannot join
- Patients must not have a history of prior radiation to the head or neck
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT
Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to produce detailed pictures of structures in the body.) In this study, cone beam CT scans will be obtained before individual radiation treatment sessions for head and neck cancer. The information gathered from these scans will be used by the researchers to look at patient movement as well as changes in the amount of normal and tumor tissue throughout the course of radiation therapy. The researchers will use this information to create hypothetical radiation treatment plans, which will be used as the basis for future research. The cone beam CT scan data will not be used to alter the actual radiation treatment of any of the patients enrolled on the study. In addition, tests of salivary output and swallowing and questionnaires about quality of life will be made to assess how the doses of radiation affect them.
- Conditions
- Head and Neck Cancer
- Being tested
- Cone Beam Computed Tomography (CT) Scan
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed Tomography (CT) ScanOther
Also called CBCT
Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer.
| Study group | Role | What they receive |
|---|---|---|
| Cone Beam CT | Experimental | All patients will be included in the treatment arm of this study. For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Although the exact amount of radiation patients get will be determined by their doctor, it is expected that they will get approximately 7 weeks, approximately 35 total cone beam CT scans. Receives: Other: Cone Beam Computed Tomography (CT) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Movement of Normal Tissue
The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
Measured: approximately 7 weeks
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
Measured: 24 months
Secondary outcomes (2)
Improvement of Image Quality
Use acquired data to further improve cone beam CT reconstruction techniques and image quality.
Measured: 36 months
The Median Delivered Dose of Radiation to the Parotid Gland
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionMar 2011
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avraham Eisbruch, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661062
- Sponsor's protocol ID
- 2005.084
- Other IDs
- HUM 757
- Status last verified
- Jul 2016
- First submitted
- 26 Sep 2011
- Last updated
- 29 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hunter KU, Fernandes LL, Vineberg KA, McShan D, Antonuk AE, Cornwall C, Feng M, Schipper MJ, Balter JM, Eisbruch A. Parotid glands dose-effect relationships based on their actually delivered doses: implications for adaptive replanning in radiation therapy of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):676-82. doi: 10.1016/j.ijrobp.2013.07.040. Epub 2013 Sep 10.
PubMed 24035328
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT
- ClinicalTrials.gov ID
- NCT01661062
- Acronym / sponsor ID
- 2005.084
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 31 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to produce detailed pictures of structures in the body.) In this study, cone beam CT scans will be obtained before individual radiation treatment sessions for head and neck cancer. The information gathered from these scans will be used by the researchers to look at patient movement as well as changes in the amount of normal and tumor tissue throughout the course of radiation therapy. The researchers will use this information to create hypothetical radiation treatment plans, which will be used as the basis for future research. The cone beam CT scan data will not be used to alter the actual radiation treatment of any of the patients enrolled on the study. In addition, tests of salivary output and swallowing and questionnaires about quality of life will be made to assess how the doses of radiation affect them.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cone Beam CT | Experimental | Other: Cone Beam Computed Tomography (CT) ScanAll patients will be included in the treatment arm of this study. For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Although the exact amount of radiation patients get will be determined by their doctor, it is expected that they will get approximately 7 weeks, approximately 35 total cone beam CT scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of all ages ≥18, both sexes, and all races will be included in this study. Pregnant females will be excluded. No other special classes of subjects (i.e., prisoners) will be entered.
- Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and neck.
- Patients must be recommended treatment with definitive radiation therapy with concurrent chemotherapy, but without prior surgical resection of the primary tumor or lymph nodes
- Patients must be recommended a treatment course of at least 30 radiation fractions
- Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Hospital indicating that they are aware that undergoing cone beam CT of the head and neck is voluntary and has potential risks.
Key exclusion criteria (1 listed)
- Patients must not have a history of prior radiation to the head or neck
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 |
|---|---|---|
| Cone Beam Computed Tomography (CT) ScanAlso: CBCTCone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer. | Other | Cone Beam CT |
Primary outcome
Rate of Movement of Normal Tissue
Time frame: approximately 7 weeks
The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
Time frame: 24 months
Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
2 secondary outcomes
Improvement of Image Quality
Time frame: 36 months
The Median Delivered Dose of Radiation to the Parotid Gland
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24035328Hunter KU, Fernandes LL, Vineberg KA, McShan D, Antonuk AE, Cornwall C, Feng M, Schipper MJ, Balter JM, Eisbruch A. Parotid glands dose-effect relationships based on their actually delivered doses: implications for adaptive replanning in radiation therapy of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):676-82. doi: 10.1016/j.ijrobp.2013.07.040. Epub 2013 Sep 10.
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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.
Avraham Eisbruch, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone Beam Computed Tomography (CT) Scan in people with Head and Neck Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 29 Aug 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Movement of Normal Tissue (time frame: approximately 7 weeks). 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?
On the ClinicalTrials.gov record for NCT01661062, which also lists 1 linked publication.
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 29 Aug 2016.