FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer

NCT00983697 | Unknown DMC

• 4 other identifiers: CDR0000654703ACRIN-6685U01CA080098U01CA079778
• Study Type: interventional
• Target: 292
• Locations: 2 countries
• Sites: 12

Brief 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. 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.

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; 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  2 years post-surgery

• Incidence of occult distant body metastasis discovered by whole body PET/CT imaging

  Within Two Weeks Before Surgery

• Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results

  Within Two Weeks Before Surgery

Study Arms (1)

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.

Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18

Interventions

therapeutic conventional surgery PROCEDURE

FDG PET/CT

fludeoxyglucose F 18 RADIATION

FDG PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Morton Plant Mease Cancer Care at Mease Countryside Hospital

Safety Harbor, Florida, 34695, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Jewish Hospital Heart and Lung Institute

Louisville, Kentucky, 40245, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Related Publications (1)

• 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.

  PMID: 30768363 RESULT

Related Links

• National Cancer Institute's clinical trials database

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Val J. Lowe, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: April 1, 2010
• Primary Completion: January 15, 2019
• Study Completion: December 1, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: by request 6+ mo after publication available through The Cancer Imaging Archive expected 1-year after publication.
• Access Criteria: Safe-Harbor deidentified data

Locations

US (11); CN (1)