Lung CancerNCT01188486
Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
A study testing Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) and Cyberknife in people with Lung Cancer and Lung Cancer Non-Small Cell Cancer (NSCLC), run by Stanford University at 1 site in United States.
Trial summary
The stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy with lymphadenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC)
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) and Cyberknife
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 30 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either:
- Established primary lung cancer/ cancer metastatic to lung, OR
- Lesion suspicious for malignancy in lung, according to the following criteria:
- Histopathologically confirmed lung cancer or cancer metastatic to lung, OR
- Plan for biopsy of suspicious lung mass based on imaging (growth on serial CT scan or nodule/mass with focal hypermetabolism on FDG-PET scan), OR
- Known metastatic cancer, with metastases to the lung based on imaging
Show all 9Show fewer
- Age > 18 years old
- Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix IV)
- No prior surgery, chemotherapy, or radiation for the current lung tumor
Who cannot join
- Prior radiotherapy to thorax
- Iodine allergy
- Contraindication to receiving radiotherapy, unless undergoing surgery
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy with lymphadenectomy. This procedure (lobectomy) does not fulfill the medical need as many patients are poor operative candidates or decline surgery.
This study assesses the feasibility of stereotactic body radiation therapy (SBRT) as a tool to produce therapeutically useful computed tomography (CT) scans, using standard water-soluble iodinated compounds as the contrast agents.
Read the detailed description
Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from phase 1-2 studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.
Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.
We propose to conduct a study to determine the feasibility of visualizing, by computed tomography (CT) scans, water-soluble iodinated contrast materials after direct injection into the tumor. Integration into radiation therapy treatment planning may also be assessed.
- Conditions
- Lung Cancer, Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Mesothelioma
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT), Cyberknife, Trilogy, True Beam
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Standard of care diagnostic radiotherapy procedure
Computed Tomography (CT)Radiation
For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the water-soluble contrast
CyberknifeDevice
Linear accelerator for producing high energy x-rays for radiation therapy.
TrilogyDevice
Linear accelerator for producing high energy x-rays for radiation therapy.
True BeamDevice
Linear accelerator for producing high energy x-rays for radiation therapy.
IohexolDrug
Also called Omnipaque, Omnipaque in Rediflo prefilled cartridges, Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide
Aqueous solution of a nonionic, water-soluble radiographic contrast medium in prefilled cartridges with a molecular weight of 821.14 (iodine content 46.36%), available at 140, 180, 240, 300, and 350 mgI/mL.
IodixanolDrug
Also called Visipaque, 5,5´-[(2-hydroxy-1,3-propanediyl)bis (acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6- triiodo-1,3- benzenedicarboxamide]
Aqueous solution of a nonionic, water-soluble, dimeric, isosmolar, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%), available in 2 concentrations, (270 mgI/mL and 320 mgI/mL.
| Study group | Role | What they receive |
|---|---|---|
| pulmonary interstitial lymphography | Experimental | stereotactic body radiation therapy \& pulmonary interstitial lymphography Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Radiation: Computed Tomography (CT); Device: Cyberknife; Device: Trilogy; Device: True Beam; Drug: Iohexol; Drug: Iodixanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting
Measured: 15 months
Secondary outcomes (1)
- Feasibility of incorporating primary nodal drainage into radiation therapy planning process
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startAug 2010
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Why it stopped: Business decision
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 Stanford 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Billy W. Loo Jr., Stanford University
- Investigators
- Billy W Loo, Jr, MD, PhD, Principal investigator, Stanford UniversityJonathan Abelson, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188486
- Sponsor's protocol ID
- IRB-18395
- Other IDs
- LUN0040
- Status last verified
- Apr 2018
- First submitted
- 23 Aug 2010
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT01188486
- Acronym / sponsor ID
- IRB-18395
- Conditions
- Lung Cancer, Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Mesothelioma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 25 Aug 2010 (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 stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy with lymphadenectomy. This procedure (lobectomy) does not fulfill the medical need as many patients are poor operative candidates or decline surgery.
This study assesses the feasibility of stereotactic body radiation therapy (SBRT) as a tool to produce therapeutically useful computed tomography (CT) scans, using standard water-soluble iodinated compounds as the contrast agents.
Detailed description
Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from phase 1-2 studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.
Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.
We propose to conduct a study to determine the feasibility of visualizing, by computed tomography (CT) scans, water-soluble iodinated contrast materials after direct injection into the tumor. Integration into radiation therapy treatment planning may also be assessed.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary interstitial lymphography | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Radiation: Computed Tomography (CT), Device: Cyberknife, Device: Trilogy, Device: True Beam, Drug: Iohexol, Drug: Iodixanolstereotactic body radiation therapy \& pulmonary interstitial lymphography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Either:
- Age > 18 years old
- Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix IV)
- No prior surgery, chemotherapy, or radiation for the current lung tumor
Key exclusion criteria (4 listed)
- Prior radiotherapy to thorax
- Iodine allergy
- Contraindication to receiving radiotherapy, unless undergoing surgery
- Pregnant
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Standard of care diagnostic radiotherapy procedure | Radiation | pulmonary interstitial lymphography |
| Computed Tomography (CT)For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the water-soluble contrast | Radiation | pulmonary interstitial lymphography |
| CyberknifeLinear accelerator for producing high energy x-rays for radiation therapy. | Device | pulmonary interstitial lymphography |
| TrilogyLinear accelerator for producing high energy x-rays for radiation therapy. | Device | pulmonary interstitial lymphography |
| True BeamLinear accelerator for producing high energy x-rays for radiation therapy. | Device | pulmonary interstitial lymphography |
| IohexolAlso: Omnipaque, Omnipaque in Rediflo prefilled cartridges, Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamideAqueous solution of a nonionic, water-soluble radiographic contrast medium in prefilled cartridges with a molecular weight of 821.14 (iodine content 46.36%), available at 140, 180, 240, 300, and 350 mgI/mL. | Drug | pulmonary interstitial lymphography |
| IodixanolAlso: Visipaque, 5,5´-[(2-hydroxy-1,3-propanediyl)bis (acetylimino)] bis[N,N´-bis(2,3-dihydroxypropyl)-2,4,6- triiodo-1,3- benzenedicarboxamide]Aqueous solution of a nonionic, water-soluble, dimeric, isosmolar, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%), available in 2 concentrations, (270 mgI/mL and 320 mgI/mL. | Drug | pulmonary interstitial lymphography |
Primary outcome
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting
Time frame: 15 months
1 secondary outcome
- Feasibility of incorporating primary nodal drainage into radiation therapy planning process
Time frame: 15 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Billy W Loo, Jr, MD, PhD principal investigator
Stanford University
Jonathan Abelson, MD principal investigator
Stanford 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 Stereotactic Body Radiation Therapy (SBRT), Computed Tomography (CT) and Cyberknife in people with Lung Cancer and Lung Cancer Non-Small Cell Cancer (NSCLC), run by Stanford 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 9 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: stopped early, as of the sponsor's last update on 17 Apr 2018. 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 was stopped early (reason given: Business decision). 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?
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting (time frame: 15 months). 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 17 Apr 2018.