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Adaptive Pet Study

Primary Purpose

Head and Neck Cancers, Lung and Esophagus Cancers, Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET-CT
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancers

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of carcinoma
  • Patients with local or regional nodal disease are eligible.
  • Zubrod Performance Status 0, 1, or 2.
  • Age ≥ 18
  • Negative serum pregnancy test for women of child bearing potential
  • Patient must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

  • No gross disease visible on imaging at the start of radiotherapy
  • Contraindication to PET
  • Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
  • Breast feeding

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET-CT

Arm Description

Outcomes

Primary Outcome Measures

The number of subjects with benefit from an intra-treatment PET-CT
This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.

Secondary Outcome Measures

Locoregional control.
This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.
Freedom from distant metastases
Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.
Measure overall survival (OS)
Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site.
Measure acute toxicities
Acute toxicity will be assessed weekly as per the standard practice of the treating investigator.
Measure late toxicities
Subjects will be evaluated in regular follow up with measures of treatment related side effects.

Full Information

First Posted
July 19, 2013
Last Updated
April 25, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01908504
Brief Title
Adaptive Pet Study
Official Title
F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancers, Lung and Esophagus Cancers, Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET-CT
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
PET-CT
Intervention Description
At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
Primary Outcome Measure Information:
Title
The number of subjects with benefit from an intra-treatment PET-CT
Description
This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Locoregional control.
Description
This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.
Time Frame
Day of intra treatment PET-CT/ approx 2-4 hours
Title
Freedom from distant metastases
Description
Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.
Time Frame
3 years
Title
Measure overall survival (OS)
Description
Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site.
Time Frame
3 years
Title
Measure acute toxicities
Description
Acute toxicity will be assessed weekly as per the standard practice of the treating investigator.
Time Frame
During radiation therapy and within 30 days of the last radiation treatment
Title
Measure late toxicities
Description
Subjects will be evaluated in regular follow up with measures of treatment related side effects.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of carcinoma Patients with local or regional nodal disease are eligible. Zubrod Performance Status 0, 1, or 2. Age ≥ 18 Negative serum pregnancy test for women of child bearing potential Patient must sign study-specific informed consent prior to study entry. Exclusion Criteria: No gross disease visible on imaging at the start of radiotherapy Contraindication to PET Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy) Breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junzo Chino, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32800802
Citation
Mowery YM, Vergalasova I, Rushing CN, Choudhury KR, Niedzwiecki D, Wu Q, Yoo DS, Das S, Wong TZ, Brizel DM. Early 18F-FDG-PET Response During Radiation Therapy for HPV-Related Oropharyngeal Cancer May Predict Disease Recurrence. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):969-976. doi: 10.1016/j.ijrobp.2020.08.029. Epub 2020 Aug 13.
Results Reference
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Adaptive Pet Study

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