Head and Neck CancerNCT01768442
MRI for Eval Tumor & Node Response & Normal Tissue Function to Concurrent Chemo & Radiation Therapy in H&N Cancer (GCC1043)
An observational study of Head and Neck Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The investigators' goal is to incorporate advanced imaging information into the treatment planning process and assess response in tumor, nodes and non-cancerous tissues in head and neck cancer patients during and after concurrent chemotherapy and radiation therapy (chemoRT) via biophysical, biochemical and vascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jan 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit patients with locally advanced head and neck cancer into the study. The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function (salivary gland and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Who may be able to join
- 1 Subjects must be 18 years or older.
- 2 Subjects must have Stage III or IV head and neck cancer.
- 3 Subjects must be undergoing concurrent chemotherapy and radiation with or without induction chemotherapy for head and neck cancers.
- 4 Subjects must be capable of giving informed consent.
- 5 Subjects must not be claustrophobic.
- 6 Patients with conditions or using medications that may contribute to xerostomia will not be excluded in this pilot study, but medical conditions and medications will be documented.
- 7 Macroscopic disease at presentation (at least T2 and/or >2cm lymph node) based on radiographic imaging.
Who cannot join
- 1 Subjects with pacemakers.
- 2 Subjects who have metallic ferromagnetic implants or pumps.
- 3 Subjects who are pregnant. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'), intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam.
- 5 Subjects with kidney disease of any severity or on hemodialysis.
- 6 Subjects with known allergies to gadolinium-based contrast agents.
- 7 Subjects incapable of lying on their backs for up to an hour at a time.
- 8 Subjects who have a tracheostomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: GCC1043: Magnetic Resonance Imaging for Evaluating Tumor and Node Response and Normal Tissue Function to Concurrent Chemotherapy and Radiation Therapy in Head and Neck Cancer
The investigators' goal is to incorporate advanced imaging information into the treatment planning process and assess response in tumor, nodes and non-cancerous tissues in head and neck cancer patients during and after concurrent chemotherapy and radiation therapy (chemoRT) via biophysical, biochemical and vascular imaging using magnetic resonance imaging (MRI). The investigators will recruit 30 patients with locally advanced head and neck cancer into the study. All patients will obtain an advanced MRI study at three time points: 1) before the start of chemoRT, 2) 4 weeks following the start of chemoRT, and 3) 3-4 months following completion of chemoRT. MRI scans will include a) T1, T2 and T2* imaging, b) vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. The subject's response (tumor, nodes and salivary and mucosal tissues) will be evaluated using clinical outcomes. Correlations will be generated between the parameters obtained from MR images and from clinical response assessments.
The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function (salivary gland and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Read the detailed description
MRI scans will be performed at three time points. The time points will be 1-2 weeks prior to the start of treatment, between 4 and 5 weeks after the start of treatment (i.e., after the 20th radiation treatment fraction and before the start of the 25th radiation treatment fraction), and 3-4 months after the completion of chemoRT. Scans acquired at the first and third time points will be clinically indicated (except for the spectroscopy scan) and ordered by the treating physician. The scan session corresponding to the second time point will be for research purposes. The investigators chose 4-5 weeks as the time point for predicting early response to chemoRT for the following reason. In a 7-week treatment regimen, an indicator tested at > 5 weeks would have limited predictive utility in the consideration of an alternative therapy, i.e., surgical intervention. However, an indicator measured at <= 5 weeks (i.e., with enough time remaining to the end of therapy) might potentially inform the therapeutic course of action in future studies. If this pilot study demonstrates utility of advanced MR imaging techniques identified at 4-5 weeks, future studies could focus on the optimal timing for assessment of early response. The time point of 3-4 months is selected for assessing post-therapy response because it coincides with the clinical follow-up schedule (at which an image-based assessment of response is performed via a clinical exam and/or PET imaging) that determines the standard of care response.
T1, T2, and T2* MRI scans will be performed to delineate head and neck tissues. DCE MRI scans will provide quantitative assessment of contrast uptake in tissues and tissue vasculature both during and at follow-up after completion of chemoRT. Contrast on images will be provided by a gadolinium-based contrast agent (GBCA). GBCA is FDA-approved and is routinely used in dynamic contrast-enhanced MRI scans. Further, contrast enhanced MRI is typically obtained on all cancer patients including head and neck cancer as part of routine clinical care. Diffusion MRI scans will provide information on the diffusion of water molecules in tumor, nodes and other head and neck tissues. MR spectroscopy scans will provide information on tissue metabolites. All scans acquired prior to the start of chemoRT will provide baseline maps against which functional maps acquired during and after completion of chemoRT will be compared to determine the relative change in anatomical, biophysical and biochemical parameters.
Image anatomy and parameter maps will be correlated with dose maps derived from CT images by registering (fusing) MRI images with CT images acquired as part of standard of care and used for treatment planning of the subject's radiation treatment.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Using MR imaging techniques to determine tumor and node response during and post chemoRT
To assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Measured: 16 months
Secondary outcomes (1)
Predictability of MR imaging techniques during and post chemoRT
- To assess whether advanced MR imaging techniques can be used to predict early at-risk organ function (salivary gland and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Warren D'Souza, PhD, Principal investigator, University of Maryland Dept. of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768442
- Sponsor's protocol ID
- HP-00047152
- Status last verified
- Sep 2019
- First submitted
- 9 Jan 2013
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCC1043: Magnetic Resonance Imaging for Evaluating Tumor and Node Response and Normal Tissue Function to Concurrent Chemotherapy and Radiation Therapy in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01768442
- Acronym / sponsor ID
- HP-00047152
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 15 Jan 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 investigators' goal is to incorporate advanced imaging information into the treatment planning process and assess response in tumor, nodes and non-cancerous tissues in head and neck cancer patients during and after concurrent chemotherapy and radiation therapy (chemoRT) via biophysical, biochemical and vascular imaging using magnetic resonance imaging (MRI). The investigators will recruit 30 patients with locally advanced head and neck cancer into the study. All patients will obtain an advanced MRI study at three time points: 1) before the start of chemoRT, 2) 4 weeks following the start of chemoRT, and 3) 3-4 months following completion of chemoRT. MRI scans will include a) T1, T2 and T2* imaging, b) vascular images using dynamic contrast enhanced (DCE) imaging, c) biophysical microstructure images using diffusion-weighted imaging, and d) biochemical images using MR spectroscopic imaging. The subject's response (tumor, nodes and salivary and mucosal tissues) will be evaluated using clinical outcomes. Correlations will be generated between the parameters obtained from MR images and from clinical response assessments.
The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function (salivary gland and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Detailed description
MRI scans will be performed at three time points. The time points will be 1-2 weeks prior to the start of treatment, between 4 and 5 weeks after the start of treatment (i.e., after the 20th radiation treatment fraction and before the start of the 25th radiation treatment fraction), and 3-4 months after the completion of chemoRT. Scans acquired at the first and third time points will be clinically indicated (except for the spectroscopy scan) and ordered by the treating physician. The scan session corresponding to the second time point will be for research purposes. The investigators chose 4-5 weeks as the time point for predicting early response to chemoRT for the following reason. In a 7-week treatment regimen, an indicator tested at > 5 weeks would have limited predictive utility in the consideration of an alternative therapy, i.e., surgical intervention. However, an indicator measured at <= 5 weeks (i.e., with enough time remaining to the end of therapy) might potentially inform the therapeutic course of action in future studies. If this pilot study demonstrates utility of advanced MR imaging techniques identified at 4-5 weeks, future studies could focus on the optimal timing for assessment of early response. The time point of 3-4 months is selected for assessing post-therapy response because it coincides with the clinical follow-up schedule (at which an image-based assessment of response is performed via a clinical exam and/or PET imaging) that determines the standard of care response.
T1, T2, and T2* MRI scans will be performed to delineate head and neck tissues. DCE MRI scans will provide quantitative assessment of contrast uptake in tissues and tissue vasculature both during and at follow-up after completion of chemoRT. Contrast on images will be provided by a gadolinium-based contrast agent (GBCA). GBCA is FDA-approved and is routinely used in dynamic contrast-enhanced MRI scans. Further, contrast enhanced MRI is typically obtained on all cancer patients including head and neck cancer as part of routine clinical care. Diffusion MRI scans will provide information on the diffusion of water molecules in tumor, nodes and other head and neck tissues. MR spectroscopy scans will provide information on tissue metabolites. All scans acquired prior to the start of chemoRT will provide baseline maps against which functional maps acquired during and after completion of chemoRT will be compared to determine the relative change in anatomical, biophysical and biochemical parameters.
Image anatomy and parameter maps will be correlated with dose maps derived from CT images by registering (fusing) MRI images with CT images acquired as part of standard of care and used for treatment planning of the subject's radiation treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit patients with locally advanced head and neck cancer into the study. The purpose of this study is to assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer, and to assess whether advanced MR imaging techniques can be used to predict early at-risk organ function (salivary gland and mucosal injury) as measured by salivary flow and oral mucositis to chemoradiation therapy (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
Key inclusion criteria (7 listed)
- 1 Subjects must be 18 years or older.
- 2 Subjects must have Stage III or IV head and neck cancer.
- 3 Subjects must be undergoing concurrent chemotherapy and radiation with or without induction chemotherapy for head and neck cancers.
- 4 Subjects must be capable of giving informed consent.
- 5 Subjects must not be claustrophobic.
Key exclusion criteria (7 listed)
- 1 Subjects with pacemakers.
- 2 Subjects who have metallic ferromagnetic implants or pumps.
- 3 Subjects who are pregnant. Negative serum or urine pregnancy test prior to study entry is required. Once on the protocol, the patient will be advised and expected to implement an accepted and effective method of contraception such as oral contraceptives ('the pill'), intrauterine devices (IUD's), contraceptive implants under skin or contraceptive injections and condoms with foam.
- 5 Subjects with kidney disease of any severity or on hemodialysis.
- 6 Subjects with known allergies to gadolinium-based contrast agents.
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
Using MR imaging techniques to determine tumor and node response during and post chemoRT
Time frame: 16 months
To assess whether advanced MR imaging techniques can be used to determine tumor and node response (i) four weeks following initiation of concurrent chemoRT and (ii) after completion of chemoRT in head and neck cancer.
1 secondary outcome
Predictability of MR imaging techniques during and post chemoRT
Time frame: 16 months
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 12 Sep 2019.
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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.
Warren D'Souza, PhD principal investigator
University of Maryland Dept. of Radiation Oncology
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 Head and Neck Cancer, run by University of Maryland, Baltimore 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 7 inclusion and 7 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 12 Sep 2019. 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?
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?
Using MR imaging techniques to determine tumor and node response during and post chemoRT (time frame: 16 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 12 Sep 2019.