NCT01908504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 26, 2023

Status Verified

May 1, 2019

Enrollment Period

4.7 years

First QC Date

July 19, 2013

Last Update Submit

April 25, 2023

Conditions

Head and Neck CancersLung and Esophagus CancersAnal, Cervix, Vulvar, Vaginal, and Endometrium Cancers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Locoregional control.

    Day of intra treatment PET-CT/ approx 2-4 hours

  • Freedom from distant metastases

    3 years

  • Measure overall survival (OS)

    3 years

  • Measure acute toxicities

    During radiation therapy and within 30 days of the last radiation treatment

  • Measure late toxicities

    3 years

Study Arms (1)

PET-CT

OTHER
Other: PET-CT

Interventions

PET-CTOTHER

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.

PET-CT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 32800802DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsEsophageal NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Junzo Chino, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 25, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 26, 2023

Record last verified: 2019-05

Locations

US(1)