Cutaneous Squamous Cell Carcinoma of the Head and NeckNCT03491176
Magnetic Resonance (MR) Imaging & Blood Biomarkers for Head and Neck Cancer
An observational study of Cutaneous Squamous Cell Carcinoma of the Head and Neck and Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy. Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma of the Head and Neck, Healthy Subject, Head and Neck Cancer
- What is being tested?
- Biospecimen Collection, Magnetic Resonance Imaging and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2017to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- Biopsy proven diagnosis of squamous cell carcinoma (SCC) of head and neck mucosa. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging
- No distant metastases, based on routine staging workup
- Consent for blood collection for biomarker analysis
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
- Dispositioned to curative intent radiotherapy
- For females of child-bearing age, a negative pregnancy test
Who cannot join
- Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
- Pregnant or breast-feeding females
- Contraindications to magnetic resonance (MR) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators)
- History of claustrophobia
- Contraindications to gadolinium contrast (e.g. kidney dysfunction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients
The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy.
Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers.
This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational.
Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the prognostic value of pretreatment volumetric tumor growth velocity (TGV), weekly tumor kinetics (TK), and blood biomarkers of mucosal head and neck cancers during radiation therapy (RT), using magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
- To assess functional imaging kinetics as a marker of tumor locoregional control.
II. To correlate blood biomarkers with tumor kinetics during treatment. III. To generate preliminary data for future trials.
OUTLINE:
Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.
After completion of study, patients are followed up weekly.
- Conditions
- Cutaneous Squamous Cell Carcinoma of the Head and Neck, Healthy Subject, Head and Neck Cancer
- Being tested
- Biospecimen Collection, Magnetic Resonance Imaging, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Head and Neck Cancer, Magnetic resonance imaging, MRI, Biomarker testing, Blood draws, Questionnaires, Surveys
- 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.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood samples
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI scan
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (MRI, blood sample collection) | Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy. Receives: Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor growth velocity (TGV)
TGV is the calculated daily increase in tumor size from diagnosis to immediately before first radiotherapy (RT) treatment as measured via magnetic resonance imaging (MRI). Will use graphs and descriptive statistics to evaluate the relationship between TGV, tumor kinetics (TK), and circulating tumor cells (CTCs) with response.
Measured: Baseline and up to 2-3 months after completion of radiation therapy
Change in TK
Tumor kinetics is the weekly decrease or increase in tumor volume after initiation of radiotherapy, evaluated using MRI. Will also use generalized linear mixed models (GLMMs) to evaluate TK over time and to assess whether a difference exists between patients with complete response (CR) and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.
Measured: Baseline up to 2-3 months after radiation therapy
Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)
Will use GLMMs to evaluate CTCs over time and to assess whether a difference exists between patients with CR and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.
Measured: Baseline and up to 2-3 months after completion radiation treatment.
Secondary outcomes (1)
Locoregional control
Locoregional control is defined as 2-year disease-free survival (DFS). Proportional hazards models will be created to examine the trajectory and intercept of TK and CTCs during radiation therapy with DFS. Time-varying covariates longitudinal modeling will be used to assess the relationship between TK and CTCs.
Measured: From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start18 May 2017
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clifton D Fuller, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491176
- Sponsor's protocol ID
- PA16-1041
- Other IDs
- NCI-2018-02631, PA16-1041
- Status last verified
- May 2026
- First submitted
- 23 Mar 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng SP, Bahig H, Wang J, Cardenas CE, Lucci A, Hall CS, Meas S, Sarli VN, Yuan Y, Urbauer DL, Ding Y, Ikner S, Dinh V, Elgohari BA, Johnson JM, Skinner HD, Gunn GB, Garden AS, Phan J, Rosenthal DI, Morrison WH, Frank SJ, Hutcheson KA, Mohamed ASR, Lai SY, Ferrarotto R, MacManus MP, Fuller CD. Predicting treatment Response based on Dual assessment of magnetic resonance Imaging kinetics and Circulating Tumor cells in patients with Head and Neck cancer (PREDICT-HN): matching 'liquid biopsy' and quantitative tumor modeling. BMC Cancer. 2018 Sep 19;18(1):903. doi: 10.1186/s12885-018-4808-5.
PubMed 30231854
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Tumor Imaging Kinetics and Blood Biomarkers in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT03491176
- Acronym / sponsor ID
- PA16-1041
- Conditions
- Cutaneous Squamous Cell Carcinoma of the Head and Neck, Healthy Subject, Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Magnetic resonance imaging, MRI, Biomarker testing, Blood draws, Questionnaires, Surveys
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 May 2017 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Apr 2018 (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.
The goal of this research study is to find out if using additional MRIs and biomarker testing can help researchers learn to predict how the tumor may change during radiation therapy.
Biomarkers are found in the blood/tissue and may be related to participant's reaction to treatment. Biomarker testing in the study may include genetic biomarkers.
This is an investigational study. MRIs on this study are performed using FDA-approved and commercially available methods. Having added scans and blood tests is investigational.
Up to 100 participants will be enrolled in this study (up to 80 patients and up to 20 healthy volunteers in another part of the study). All will take part at MD Anderson.
Detailed description
PRIMARY OBJECTIVES:
- To assess the prognostic value of pretreatment volumetric tumor growth velocity (TGV), weekly tumor kinetics (TK), and blood biomarkers of mucosal head and neck cancers during radiation therapy (RT), using magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
- To assess functional imaging kinetics as a marker of tumor locoregional control.
II. To correlate blood biomarkers with tumor kinetics during treatment. III. To generate preliminary data for future trials.
OUTLINE:
Patients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy.
After completion of study, patients are followed up weekly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (MRI, blood sample collection) | – | Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo MRI scans and collection of blood samples for biomarker testing pre-radiation therapy, weekly during radiation therapy, and at 2-3 months post-radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (7 listed)
- Biopsy proven diagnosis of squamous cell carcinoma (SCC) of head and neck mucosa. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging
- No distant metastases, based on routine staging workup
- Consent for blood collection for biomarker analysis
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
- Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
Key exclusion criteria (5 listed)
- Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e. oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity)
- Pregnant or breast-feeding females
- Contraindications to magnetic resonance (MR) imaging (e.g. implanted metallic prostheses, defibrillators, or stimulators)
- History of claustrophobia
- Contraindications to gadolinium contrast (e.g. kidney dysfunction)
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood samples | Procedure or surgery | Diagnostic (MRI, blood sample collection) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI scan | Procedure or surgery | Diagnostic (MRI, blood sample collection) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Diagnostic (MRI, blood sample collection) |
| Questionnaire AdministrationAncillary studies | Other | Diagnostic (MRI, blood sample collection) |
Primary outcome
Tumor growth velocity (TGV)
Time frame: Baseline and up to 2-3 months after completion of radiation therapy
TGV is the calculated daily increase in tumor size from diagnosis to immediately before first radiotherapy (RT) treatment as measured via magnetic resonance imaging (MRI). Will use graphs and descriptive statistics to evaluate the relationship between TGV, tumor kinetics (TK), and circulating tumor cells (CTCs) with response.
Change in TK
Time frame: Baseline up to 2-3 months after radiation therapy
Tumor kinetics is the weekly decrease or increase in tumor volume after initiation of radiotherapy, evaluated using MRI. Will also use generalized linear mixed models (GLMMs) to evaluate TK over time and to assess whether a difference exists between patients with complete response (CR) and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.
Change in Blood Biomarkers of Mucosal Head and Neck Cancers During Radiation Therapy (RT)
Time frame: Baseline and up to 2-3 months after completion radiation treatment.
Will use GLMMs to evaluate CTCs over time and to assess whether a difference exists between patients with CR and those without CR. Will use graphs and descriptive statistics to evaluate the relationship between TGV, TK, and CTCs with response.
1 secondary outcome
Locoregional control
Time frame: From date of first treatment to date of death, disease progression or recurrence, whichever occurs first, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 30231854Ng SP, Bahig H, Wang J, Cardenas CE, Lucci A, Hall CS, Meas S, Sarli VN, Yuan Y, Urbauer DL, Ding Y, Ikner S, Dinh V, Elgohari BA, Johnson JM, Skinner HD, Gunn GB, Garden AS, Phan J, Rosenthal DI, Morrison WH, Frank SJ, Hutcheson KA, Mohamed ASR, Lai SY, Ferrarotto R, MacManus MP, Fuller CD. Predicting treatment Response based on Dual assessment of magnetic resonance Imaging kinetics and Circulating Tumor cells in patients with Head and Neck cancer (PREDICT-HN): matching 'liquid biopsy' and quantitative tumor modeling. BMC Cancer. 2018 Sep 19;18(1):903. doi: 10.1186/s12885-018-4808-5.
- MD Anderson Cancer Center WebsiteLink 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.
Clifton D Fuller principal investigator
M.D. Anderson Cancer Center
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 Cutaneous Squamous Cell Carcinoma of the Head and Neck and Healthy Subject, run by M.D. Anderson 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tumor growth velocity (TGV) (time frame: Baseline and up to 2-3 months after completion of radiation therapy). The study lists 3 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 NCT03491176, 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 20 May 2026.