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Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer

Primary Purpose

Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Malignant Neoplasm in the Spine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fludeoxyglucose F-18
Positron Emission Tomography
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation

Exclusion Criteria:

  • Children
  • No evidence of cervical nodal metastasis
  • Active infection of the head and neck
  • Known allergy to FDG, iodine or gadolinium-based contrast agents
  • Blood glucose (> 250 mg/dl)
  • Pregnant women

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (FDG PET/CT)

Arm Description

Patients receive fludeoxyglucose F-18 IV over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard CRT completion.

Outcomes

Primary Outcome Measures

Optimal imaging time
Determined by fludeoxyglucose F-18 (FDG) positron emission tomography. The optimal time point is defined as the time point that meets the following requirements: 1) it has the largest average lesion/background (L/B) ratio, and 2) if the delayed time point is greater, it must be significantly different from the initial time point at the 0.025 significance level. The acquired PET data will be reconstructed using iterative techniques with resolution recovery. All delayed time points will then be registered using rigid techniques to the standard of care initial PET/CT image. Volumes of interest around the largest nodal metastasis will be drawn and the standard uptake value (SUV) max will be calculated. A corresponding region for largest nodal metastasis will be drawn on the contralateral sternocleidomastoid muscle respective to each lesion to determine L/B ratio, where L is the lesion SUV max and B is the corresponding background SUV max.
Differences in L/B ratio
Differences in L/B ratio between the initial and delayed time point will be tested via paired t-test after appropriate transformation.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2018
Last Updated
April 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03575949
Brief Title
Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer
Official Title
Dual-Time Point (DTP) FDG PET CT for the Post-Treatment Assessment of Head and Neck Tumors Following Definitive Chemoradiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial studies how well standard and delayed fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) given after standard radiation and chemotherapy works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body. Diagnostic procedures, such as PET/CT, use radioactive material, such as fludeoxyglucose F-18, to find and diagnose head and neck tumors and may help to find out how far the disease has spread.
Detailed Description
PRIMARY OBJECTIVE: I. To assess the optimal imaging time using FDG positron emission tomography (PET) with comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours scan (delayed) post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background [L/B] ratio) in patients with head and neck primary squamous cell carcinoma following chemoradiation treatment. OUTLINE: Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard chemoradiation (CRT) completion. After completion of study, patients are followed up at 30 days and then periodically for up to 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Malignant Neoplasm in the Spine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (FDG PET/CT)
Arm Type
Experimental
Arm Description
Patients receive fludeoxyglucose F-18 IV over 1 minute and undergo PET/CT at 70 and 180 minutes after injection at 12-14 weeks following standard CRT completion.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT scan, Computerized Axial Tomography, computerized tomography, CT, CT scan, tomography
Intervention Description
Undergo FDG PET/CT
Intervention Type
Other
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo FDG PET/CT
Primary Outcome Measure Information:
Title
Optimal imaging time
Description
Determined by fludeoxyglucose F-18 (FDG) positron emission tomography. The optimal time point is defined as the time point that meets the following requirements: 1) it has the largest average lesion/background (L/B) ratio, and 2) if the delayed time point is greater, it must be significantly different from the initial time point at the 0.025 significance level. The acquired PET data will be reconstructed using iterative techniques with resolution recovery. All delayed time points will then be registered using rigid techniques to the standard of care initial PET/CT image. Volumes of interest around the largest nodal metastasis will be drawn and the standard uptake value (SUV) max will be calculated. A corresponding region for largest nodal metastasis will be drawn on the contralateral sternocleidomastoid muscle respective to each lesion to determine L/B ratio, where L is the lesion SUV max and B is the corresponding background SUV max.
Time Frame
Up to 6 months
Title
Differences in L/B ratio
Description
Differences in L/B ratio between the initial and delayed time point will be tested via paired t-test after appropriate transformation.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult with computed tomography (CT) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation Exclusion Criteria: Children No evidence of cervical nodal metastasis Active infection of the head and neck Known allergy to FDG, iodine or gadolinium-based contrast agents Blood glucose (> 250 mg/dl) Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Johnson
Phone
713-792-8443
Email
jjohnson12@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Johnson
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason M. Johnson
Phone
713-792-8443
Email
jjohnson12@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jason M. Johnson

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Standard and Delayed FDG PET/CT After Chemoradiation Therapy in Assessing Patients With Metastatic Head and Neck Squamous Cell Cancer

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