SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy

NCT01982123 | Completed Results

• 3 other identifiers: 8180NCI-2013-01774P30CA015704
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.

Conditions

Lung Carcinoma; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT

  Perfusion and ventilation on SPECT/CT pre-radiation, mid-radiation, and post-radiation were compared to assess stability over time. Coefficient of determination (R²) was generated based on voxel-based comparisons between scans (R²=1 means perfect reproducibility in perfusion and ventilation between scans), based on regions outside the radiation field.

  Baseline to up to 3 months post-treatment

Secondary Outcomes (1)

• Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT

  Baseline to up to 3 months post-treatment

Study Arms (1)

SPECT/CT Mid-& Post-RT

EXPERIMENTAL

Investigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment.

Diagnostic Test: SPECT/CT; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium Tc-99m Albumin Aggregated; Drug: Technetium Tc-99m DTPA

Interventions

SPECT/CT DIAGNOSTIC_TEST

Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation

SPECT/CT Mid-& Post-RT

Single Photon Emission Computed Tomography PROCEDURE

Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT

Also known as: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon

SPECT/CT Mid-& Post-RT

Technetium Tc-99m Albumin Aggregated RADIATION

Undergo 99mTc-MAA SPECT/CT

Also known as: Tc 99m-labeled MAA, Technetium Tc 99m-Labeled Macroaggregated Albumin

SPECT/CT Mid-& Post-RT

Technetium Tc-99m DTPA DRUG

Undergo 99mTc-DTPA SPECT/CT

Also known as: 99m-technetium Diethylenetriaminepentaacetic Acid, Tc-99m-DTPA, Tc-DTPA

SPECT/CT Mid-& Post-RT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients receiving radiation treatment to the thorax to at least 45 Gy; patient must have pathologic confirmation of diagnosis, or have an enlarging lung mass on at least two scans spaced 3 months apart, and FDG avidity on PET scan
• Patients must be planned for at least 45 Gy of thoracic radiation
• Patients are not required to have measurable disease; post-operative patients (patients who have had surgical resection of the lung) are eligible
• Patients must have pulmonary function as defined below:
• Abnormal pulmonary function test within 3 months of study entry
• Prior radiation to the lungs
• Prior surgical resection of lung tissue (i.e. wedge resection, lobectomy, or pneumonectomy)
• Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
• Ongoing oxygen use
• There are no limits on prior therapy; patients are allowed to have prior chemotherapy, radiation therapy, and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy after radiation treatment; patients are not allowed to have planned lung resection after radiation
• Ability to understand and the willingness to sign a written informed consent document
• Patients will typically be enrolled on this trial prior to beginning the radiation treatment course; however, if a patient has had a SPECT/CT 99mTc-MAA and 99mTc-DTPA scan as part of routine medical care within 6 weeks prior to initiation of radiation treatment, he/she is eligible for trial enrollment up to the last day of the radiation treatment course

You may not qualify if:

• Patients must not be planned for lung resection after radiation therapy
• Patients receiving \< 45 Gy radiation
• Patients who received radiation to the chest within the past 6 months
• Patients unable to tolerate a SPECT/CT 99mTc-MAA and 99mTc-DTPA scan
• Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol
• Pregnant women
• Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
• Patients unable to provide informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

ProCure Proton Therapy Center-Seattle

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Single Photon Emission Computed Tomography Computed Tomography; X-Rays; Photons; Technetium Tc 99m Aggregated Albumin; Technetium Tc 99m Pentetate

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Organotechnetium Compounds; Organometallic Compounds; Organic Chemicals; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Pentetic Acid; Polyamines; Amines; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: Dr. Jing Zeng
• Organization: University of Washington Medical Center

jzeng13@uw.edu

2065984110

Study Officials

• Jing Zeng

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 13, 2013
• Study Start: January 17, 2014
• Primary Completion: September 13, 2017
• Study Completion: September 13, 2017
• Last Updated: December 13, 2018
• Results First Posted: December 13, 2018

Record last verified: 2018-11

Locations

US (2)