Head and Neck CancerACRIN6685NCT00983697
FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
A study testing therapeutic conventional surgery and fludeoxyglucose F 18 in people with Head and Neck Cancer, run by American College of Radiology Imaging Network at 12 sites in 2 countries.
Trial summary
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment. 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?
- therapeutic conventional surgery and fludeoxyglucose F 18
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 Apr 2010to Dec 2021
- Phase
- Interventional
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and neck , including any of the following sites:
- Oral cavity
- Oropharynx, including base of tongue and tonsils
- Larynx
- Supraglottis
- Stage T2-T4, N0-N3 disease
- Unilateral or bilateral neck dissection planned
- No N2c disease (if bilateral disease is present)
- Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with CT scan and/or MRI)
- A N0 neck must be planned to be dissected for the patient to be eligible
- . The N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned
- CT scan and/or MRI taken within the past 4 weeks to confirm SCC of the head and neck
- Simultaneous diagnostic CT with PET scan allowed; however, PET cannot be used as part of the criteria to define the N0 neck disease
- For CT scan and/or MR images from other institutions, ACRIN recommends a re-read by a local neuro-radiologist to ensure compliance
- No sinonasal cancer, salivary gland cancer, thyroid cancer, nasopharyngeal cancer, or advanced skin cancer
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Weight ≤ 350 lbs
- No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications (optimally, patients will have glucose < 150 mg/dL)
- No underlying medical condition that would preclude surgery (neck dissection)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181
Jewish Hospital Heart and Lung Institute
Louisville, Kentucky, 40245
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Morton Plant Mease Cancer Care at Mease Countryside Hospital
Safety Harbor, Florida, 34695
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery.
- Determine the potential of PET/CT imaging to change treatment.
Secondary
- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local sites.
- Determine the effect of other factors (e.g., tumor size, location, secondary primary tumors, or intensity of FDG uptake) that can lead to identification of subsets of patients that could potentially forego neck dissection or that can provide preliminary data for subsequent studies.
- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices.
- Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging.
- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
- Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results.
- Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction.
- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.
- Determine the proportion of neck dissections that are extended (i.e., additional levels that clinicians intend to dissect beyond the initial surgery plan) based on local-reader PET/CT imaging findings shared with the surgeon before dissection.
- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging.
- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location).
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.
Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months after surgery.
Patients undergo blood and tissue sample collection periodically for biomarker analysis.
Patients are followed up periodically for up to 2 years after surgery.
- Conditions
- Head and Neck Cancer
- Being tested
- therapeutic conventional surgery, fludeoxyglucose F 18
- Keywords
- stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage II verrucous carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, tongue cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic conventional surgeryProcedure or surgery
fludeoxyglucose F 18Radiation
| Study group | Role | What they receive |
|---|---|---|
| FDG PET/CT | Experimental | Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol. Receives: Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
True negative cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise.
Measured: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Secondary outcomes (13)
Sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinically N0 neck (both by neck and lymph node regions) or other local sites
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
Measured: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Determine which factors (e.g., tumor size, secondary primary tumors, location, or intensity of FDG uptake) may identify patients who can forego neck dissection
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
Measured: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices
The outcome measure will use the total cost of care for each participant to compute the incremental cost-effectiveness ratio (ICER)
Measured: 2 years post-surgery
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging
this outcome will count the distant body metastasis not previously seen and report the results as a percentage.
Measured: Within Two Weeks Before Surgery
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results
the outcome measure will consist of paired proportions of dichotomized PET/CT and CT/MRI test results; and biomarker test results
Measured: Within Two Weeks Before Surgery
Quality of life (QOL), particularly in patients whose management could have been altered by imaging results
QOL will be assessed using SF-36, Non-Utility HUI, and UW-QoL scores
Measured: 2 years post-surgery
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction
the metastatic disease status is the response variable and PET/CT test results and biomarker data are predictors.
Measured: Within Two Weeks Before Surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence
model the associations of PET/CT test results and biomarker data (predictors) to recurrence
Measured: 2 years post-surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of disease-free survival
model the associations of PET/CT test results and biomarker data (predictors) to disease-free survival
Measured: 2 years post-surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of overall survival
model the associations of PET/CT test results and biomarker data (predictors) to overall survival (censored responses)
Measured: 2 years post-surgery
Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection
Outcome is defined as the number patients who surgeons intend to dissect levels beyond the initial surgery plan
Measured: Within Two Weeks Before Surgery
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging
ROC analysis will be used to maximize the youden index and estimate the optimum cutoff value of SUV for diagnostic accuracy of PET/CT on N0 neck
Measured: Within Two Weeks Before Surgery
Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)
Diagnostic Accuracy measures will be calculated using ROC analysis, subset by anatomic location
Measured: Within Two Weeks Before Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study start1 Apr 2010
- Primary completion15 Jan 2019
- Study completionDec 2021 (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 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Radiology Imaging Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Val J. Lowe, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983697
- Sponsor's protocol ID
- CDR0000654703
- Other IDs
- ACRIN-6685, U01CA080098, U01CA079778
- Acronym
- ACRIN6685
- Status last verified
- Oct 2020
- First submitted
- 23 Sep 2009
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: See ACRIN data sharing policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
Publications
Lowe VJ, Duan F, Subramaniam RM, Sicks JD, Romanoff J, Bartel T, Yu JQM, Nussenbaum B, Richmon J, Arnold CD, Cognetti D, Stack BC Jr. Multicenter Trial of [18F]fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Staging of Head and Neck Cancer and Negative Predictive Value and Surgical Impact in the N0 Neck: Results From ACRIN 6685. J Clin Oncol. 2019 Jul 10;37(20):1704-1712. doi: 10.1200/JCO.18.01182. Epub 2019 Feb 15.
PubMed 30768363
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT00983697
- Acronym / sponsor ID
- ACRIN6685 / CDR0000654703
- Conditions
- Head and Neck Cancer
- Keywords
- stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- American College of Radiology Imaging NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 Sep 2009 (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.
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery.
- Determine the potential of PET/CT imaging to change treatment.
Secondary
- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local sites.
- Determine the effect of other factors (e.g., tumor size, location, secondary primary tumors, or intensity of FDG uptake) that can lead to identification of subsets of patients that could potentially forego neck dissection or that can provide preliminary data for subsequent studies.
- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices.
- Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging.
- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
- Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results.
- Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction.
- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.
- Determine the proportion of neck dissections that are extended (i.e., additional levels that clinicians intend to dissect beyond the initial surgery plan) based on local-reader PET/CT imaging findings shared with the surgeon before dissection.
- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging.
- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location).
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.
Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months after surgery.
Patients undergo blood and tissue sample collection periodically for biomarker analysis.
Patients are followed up periodically for up to 2 years after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG PET/CT | Experimental | Procedure: therapeutic conventional surgery, Radiation: fludeoxyglucose F 18Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| therapeutic conventional surgery | Procedure or surgery | FDG PET/CT |
| fludeoxyglucose F 18 | Radiation | FDG PET/CT |
Primary outcome
Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
Time frame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
True negative cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise.
13 secondary outcomes
Sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinically N0 neck (both by neck and lymph node regions) or other local sites
Time frame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Determine which factors (e.g., tumor size, secondary primary tumors, location, or intensity of FDG uptake) may identify patients who can forego neck dissection
Time frame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices
Time frame: 2 years post-surgery
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging
Time frame: Within Two Weeks Before Surgery
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results
Time frame: Within Two Weeks Before Surgery
Quality of life (QOL), particularly in patients whose management could have been altered by imaging results
Time frame: 2 years post-surgery
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction
Time frame: Within Two Weeks Before Surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence
Time frame: 2 years post-surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of disease-free survival
Time frame: 2 years post-surgery
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of overall survival
Time frame: 2 years post-surgery
Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection
Time frame: Within Two Weeks Before Surgery
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging
Time frame: Within Two Weeks Before Surgery
Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)
Time frame: Within Two Weeks Before Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Results publication: PubMed 30768363Lowe VJ, Duan F, Subramaniam RM, Sicks JD, Romanoff J, Bartel T, Yu JQM, Nussenbaum B, Richmon J, Arnold CD, Cognetti D, Stack BC Jr. Multicenter Trial of [18F]fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Staging of Head and Neck Cancer and Negative Predictive Value and Surgical Impact in the N0 Neck: Results From ACRIN 6685. J Clin Oncol. 2019 Jul 10;37(20):1704-1712. doi: 10.1200/JCO.18.01182. Epub 2019 Feb 15.
- National Cancer Institute's clinical trials databaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. See ACRIN data sharing policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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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.
Val J. Lowe, MD study chair
Mayo Clinic
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic conventional surgery and fludeoxyglucose F 18 in people with Head and Neck Cancer, run by American College of Radiology Imaging Network at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, China. 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?
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?
Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes (time frame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes). 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 NCT00983697, 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 23 Oct 2020.