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AzTrials

Stage I Lung CancerPhase 1NCT03493789

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

A Phase 1 study testing Fludeoxyglucose F-18, Positron Emission Tomography (PET) and Stereotactic Body Radiation Therapy (SBRT) in people with Stage I Lung Cancer and Stage I Non-Small Cell Lung Cancer AJCC v7, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fludeoxyglucose F-18, Positron Emission Tomography (PET) and Stereotactic Body Radiation Therapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
13 Apr 2018to 19 Mar 2019
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are offered radiotherapy using a 5-fraction stereotactic body radiation therapy course, at the recommendation of the treating radiation oncologist
  • Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage lung cancer, or pulmonary metastases
  • Patients with a limited (1-5) number of metastatic foci outside of the thorax who are candidates for consolidative treatment with SBRT
  • Patient with either a single focus or multiple foci (multi-isocentric planning) of disease in the thorax amenable to SBRT with at least one focus with at least 1.5 cm or larger in its largest diameter
  • Patients who are planned to receive either chemotherapy, targeted therapy, immunotherapy, or no additional cancer-directed drug therapy

Who cannot join

  • Prior radiation therapy which would provide significant dose overlap with the planned target volume(s) delivered within 30 days of enrollment or registration
  • Major invasive surgical procedure occurring between the first treatment-eligible PET/CT examination and end of radiotherapy that would affect the treatment target region
  • Patients with minimal FDG-avidity localized to the planned treatment target (e.g. maximum standardized uptake value [SUV] < 4.0)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy

This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.

Read the detailed description

PRIMARY OBJECTIVE:

To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT).

SECONDARY OBJECTIVES:

  1. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT.

II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets.

III. To compare dosimetry for primary tumor coverage and dose to organs at risk between adaptive cone beam computed tomography (CT) planning, and simulated adaptive emission-guided radiation therapy (BgRT) planning for thoracic and non-thoracic targets.

IV. To compare variability of 18-F FDG-PET in patients undergoing immunotherapy simultaneously during SBRT, or within 4 weeks of SBRT treatment with patients undergoing SBRT but not receiving immunotherapy.

OUTLINE:

Participants receive fludeoxyglucose F-18 intravenously (IV) and after 60 minutes undergo PET within 4 weeks of the first planned SBRT fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Being tested
Fludeoxyglucose F-18, Positron Emission Tomography (PET), Stereotactic Body Radiation Therapy (SBRT)
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fludeoxyglucose F-18Drug

    Also called 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose

    Given IV

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called Medical imaging, positron emission tomography, PET scan, Positron emission tomography scan, Proton magnetic resonance spectroscopic imaging

    Undergo FDG-PET

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

    Also called SABR, Stereotactic ablative body radiation therapy

    Undergo SBRT

Study groups in NCT03493789
Study groupRoleWhat they receive
Diagnostic (FDG-PET, SBRT)ExperimentalParticipants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.
Receives: Drug: Fludeoxyglucose F-18; Procedure: Positron Emission Tomography (PET); Radiation: Stereotactic Body Radiation Therapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes

    Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

    Measured: Up to 6 weeks from study start

  2. Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes

    Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

    Measured: Up to 6 weeks from study start

Secondary outcomes (2)

  1. Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes

    Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

    Measured: Up to 6 weeks from study start

  2. Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes

    Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

    Measured: Up to 6 weeks from study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start13 Apr 2018
  3. Primary completion19 Mar 2019
  4. Study completion19 Mar 2019

Resources

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 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493789
Sponsor's protocol ID
IRB00101066
Other IDs
NCI-2018-00375, RAD4267-17, P30CA138292
Status last verified
Oct 2023
First submitted
20 Mar 2018
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fludeoxyglucose F-18, Positron Emission Tomography (PET) and Stereotactic Body Radiation Therapy (SBRT) in people with Stage I Lung Cancer and Stage I Non-Small Cell Lung Cancer AJCC v7, run by Emory 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 5 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 18 Oct 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes (time frame: Up to 6 weeks from study start). The study lists 2 primary outcomes in all. 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 NCT03493789.

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 18 Oct 2023.

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