Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Virginia Commonwealth University (VCU)

Status and phase: Terminated; Phase 1

Conditions: Lung Cancer

Treatments: Procedure: implanted fiducial-based imaging; Radiation: radiation therapy treatment planning/simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00856427

CDR0000630623 (Registry Identifier)

NCI-2013-00512 (Registry Identifier)

HM11284 (Other Identifier)

MCC-11284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Diagnostic

Experimental group

Description:

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).

Treatment:

Radiation: radiation therapy treatment planning/simulation

Procedure: implanted fiducial-based imaging