Adaptive Pet Study

Head and Neck Cancers Clinical Trial

Official title:

F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908504
• Other study ID #: Pro00033339
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: September 2016

Study information

• Verified date: May 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
• Endometrial Neoplasms
• Esophageal Neoplasms
• Head and Neck Cancers
• Lung and Esophagus Cancers

Intervention

Other:
• PET-CT
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	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.	Day of intra treatment PET-CT/ approx 2-4 hours
Secondary	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.	3 years
Secondary	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.	3 years
Secondary	Measure acute toxicities	Acute toxicity will be assessed weekly as per the standard practice of the treating investigator.	During radiation therapy and within 30 days of the last radiation treatment
Secondary	Measure late toxicities	Subjects will be evaluated in regular follow up with measures of treatment related side effects.	3 years