Head and Neck CancersNCT01908504
Adaptive Pet Study
A study testing PET-CT in people with Head and Neck Cancers and Lung and Esophagus Cancers, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancers, Lung and Esophagus Cancers, Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
- What is being tested?
- PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
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.
- Conditions
- Head and Neck Cancers, Lung and Esophagus Cancers, Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
- Being tested
- PET-CT
- Medical subject headings
- Head and Neck Neoplasms, Esophageal Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| PET-CT | Other | Not described Receives: Other: PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
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.
Measured: Day of intra treatment PET-CT/ approx 2-4 hours
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.
Measured: 3 years
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.
Measured: 3 years
Measure acute toxicities
Acute toxicity will be assessed weekly as per the standard practice of the treating investigator.
Measured: During radiation therapy and within 30 days of the last radiation treatment
Measure late toxicities
Subjects will be evaluated in regular follow up with measures of treatment related side effects.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junzo Chino, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908504
- Sponsor's protocol ID
- Pro00033339
- Status last verified
- May 2019
- First submitted
- 19 Jul 2013
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32800802
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
- ClinicalTrials.gov ID
- NCT01908504
- Acronym / sponsor ID
- Pro00033339
- Conditions
- Head and Neck Cancers, Lung and Esophagus Cancers, Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT | Other | Other: PET-CT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CTAt 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. | Other | PET-CT |
Primary outcome
The number of subjects with benefit from an intra-treatment PET-CT
Time frame: 3 years
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.
5 secondary outcomes
Locoregional control.
Time frame: Day of intra treatment PET-CT/ approx 2-4 hours
Freedom from distant metastases
Time frame: 3 years
Measure overall survival (OS)
Time frame: 3 years
Measure acute toxicities
Time frame: During radiation therapy and within 30 days of the last radiation treatment
Measure late toxicities
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 32800802Mowery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junzo Chino, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-CT in people with Head and Neck Cancers and Lung and Esophagus Cancers, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with benefit from an intra-treatment PET-CT (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.