Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Brief Title

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Official Title

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Brief 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. 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 Type

Interventional

Primary Outcome

- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting

Secondary Outcome

 - Feasibility of incorporating primary nodal drainage into radiation therapy planning process

Condition

Lung Cancer

Intervention

Stereotactic Body Radiation Therapy (SBRT)

Study Arms / Comparison Groups

 pulmonary interstitial lymphography

Description:  stereotactic body radiation therapy & pulmonary interstitial lymphography

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Radiation

Estimated Enrollment

12

Start Date

August 2010

Completion Date

April 30, 2017

Primary Completion Date

April 30, 2017

Eligibility Criteria

        INCLUSION CRITERIA

          -  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

          -  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

        EXCLUSION CRITERIA

          -  Prior radiotherapy to thorax

          -  Iodine allergy

          -  Contraindication to receiving radiotherapy, unless undergoing surgery

          -  Pregnant
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Billy W Loo, Jr, MD, PhD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01188486

Organization ID

IRB-18395

Secondary IDs

LUN0040

Responsible Party

Principal Investigator

Study Sponsor

Stanford University

Study Sponsor

Billy W Loo, Jr, MD, PhD, Principal Investigator, Stanford University

Verification Date

April 2018