Lung CancerPhase 1NCT00856427
Implantation of Markers for the Radiotherapy of Lung Cancer Patients
A Phase 1 study testing radiation therapy treatment planning/simulation and implanted fiducial-based imaging in people with Lung Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- radiation therapy treatment planning/simulation and implanted fiducial-based imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2012
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer
- Stage I-IIIB disease
- No prior surgical tumor resection
- Respiration-induced tumor motion > 5 mm
- Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals
PATIENT CHARACTERISTICS:
- Not pregnant
- No insufficient lung function or other parameters prohibiting a bronchoscopy
- Not a prisoner or institutionalized
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent chemotherapy allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298-0037
About this study
This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.
Read the detailed description
OBJECTIVES:
- To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer.
- To characterize the potential side effects involved in the use of markers in these patients.
- To analyze the positional stability of lung markers in these patients over a radiotherapy series.
- To acquire experience in the use of markers for treatment planning and radiotherapy in these patients.
OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.
- Conditions
- Lung Cancer
- Being tested
- radiation therapy treatment planning/simulation, implanted fiducial-based imaging
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer
- 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.
radiation therapy treatment planning/simulationRadiation
Undergo implantation of radio-opaque markers
implanted fiducial-based imagingProcedure or surgery
Undergo implantation of radio-opaque markers
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | Experimental | Patients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors). Receives: Radiation: radiation therapy treatment planning/simulation; Procedure: implanted fiducial-based imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dropped markers
Measured: up to 5 years
Marker misplacements
Measured: up to 5 years
Implantation-related side effects
Measured: up to 5 years
Visibility of markers on CT and x-rays
Measured: up to 5 years
Positional reliability of markers
Measured: Up to 5 years
Usability for patient treatment
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- Study completionAug 2012
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Weiss, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856427
- Sponsor's protocol ID
- MCC-11284
- Other IDs
- HM11284, CDR0000630623, NCI-2013-00512
- Status last verified
- Dec 2013
- First submitted
- 4 Mar 2009
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of Markers for the Radiotherapy of Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00856427
- Acronym / sponsor ID
- MCC-11284
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Mar 2009 (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.
This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.
Detailed description
OBJECTIVES:
- To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer.
- To characterize the potential side effects involved in the use of markers in these patients.
- To analyze the positional stability of lung markers in these patients over a radiotherapy series.
- To acquire experience in the use of markers for treatment planning and radiotherapy in these patients.
OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Radiation: radiation therapy treatment planning/simulation, Procedure: implanted fiducial-based imagingPatients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| radiation therapy treatment planning/simulationUndergo implantation of radio-opaque markers | Radiation | Diagnostic |
| implanted fiducial-based imagingUndergo implantation of radio-opaque markers | Procedure or surgery | Diagnostic |
Primary outcome
Number of dropped markers
Time frame: up to 5 years
Marker misplacements
Time frame: up to 5 years
Implantation-related side effects
Time frame: up to 5 years
Visibility of markers on CT and x-rays
Time frame: up to 5 years
Positional reliability of markers
Time frame: Up to 5 years
Usability for patient treatment
Time frame: up to 5 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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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.
Elisabeth Weiss, MD principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing radiation therapy treatment planning/simulation and implanted fiducial-based imaging in people with Lung Cancer, run by Virginia Commonwealth 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?
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: stopped early, as of the sponsor's last update on 20 Dec 2013. 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 was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Number of dropped markers (time frame: up to 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2013.