Breathing Synchronized PET/CT Scans for the Detection of Malignant Lung & Liver Lesions and Assessment of Tumor Glycolysis

NCT01052766 | Terminated

• 1 other identifier: 09-134
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

In this particular study the physicians want to use a new technique of how they obtain the PET/CT pictures. It is called breath-hold (BH) PET/CT". As the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. This is repeated several times. In contrast to the standard PET/CT scan, they expect less "blurring" of the pictures, so that they can see the tumor better and measure the uptake of radioactive sugar in the tumor better and more reliably. Basically, this is the difference between taking pictures of a runner as compared to taking pictures of a person standing still. Since PET images need to be obtained over several minutes and people can not hold their breath for this extended time, we break the procedure into several cycles of 20-30 seconds (or longer, if possible) and then add all the "frozen" pictures in the end into one. They want to know if BH PET/CT scan measure changes in the cancer during therapy (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).

Conditions

Lung Cancer; Non-small Cell Lung Cancer

Keywords

lung cancer; PET Scan; CT Scan; BH-PET scan; 09-134

Outcome Measures

Primary Outcomes (1)

• To investigate whether BH-PET scan improves detectability of the lung & liver lesions seen on breath-hold CT scans as compared to their detectability on standard clinical PET scan.

  2 years

Secondary Outcomes (2)

• To compare the magnitude of changes in SUV between pre and post therapy pet scans done as either standard clinical PET/CT or BH PET/CT.

  2 years

• To investigate whether the correlation between change in SUV and the lesion response on follow-up scan (3 months) is different for standard clinical PET/CT versus BH scan.

  2 years

Study Arms (1)

PET/CT and BH PET/CT

EXPERIMENTAL

In collaboration with the Department of Radiation Oncology and the Interventional Radiology Service, patients with lung or liver cancer or lung or liver metastases in whom FDG PET/CT is part of the clinical standard of care for disease evaluation and response assessment will be enrolled in this study. We will perform a clinical PET/CT and BH PET/CT (for two bed positions covering the entire chest) prior to, and again 1-2 weeks after SBRT or RFA. This early time point is chosen because a few weeks after the completion of treatment, acute radiation injury in the lung begins and will likely be detectable as abnormal uptake on follow-up PET imaging making it difficult to assess tumor recurrence.

Procedure: PET/CT and BH PET/CT

Interventions

PET/CT and BH PET/CT PROCEDURE

First, fiducial markers will be placed and taped on the patient's lower chest/upper abdomen. This will allow for monitoring of chest motion during breathing. A BH-CT scan will then be acquired with clinical CT scan parameters used in nuclear medicine. A BH-PET scan (acquisition time: 6 min per bed position) will follow the BH-CT scan. BH-PET images will cover the whole thorax, which, on average, corresponds to 1-3 PET FOV's (\~15 cm/FOV). Data for these 1-3 bed positions are acquired to cover the entire thorax. There will be no additional radiotracer injection for the BH-PET scan.

PET/CT and BH PET/CT

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Patients with early stage biopsy-proven lung cancer or patients with lung or liver metastases from any primary cancer (metastatic disease proven by biopsy, or clearly established clinically and by imaging studies who are being treated with stereotactic body radiotherapy (SBRT)or an ablation will be eligible.
• Patient has at least one lesion ≥ 1cm in size.
• Signed informed consent

You may not qualify if:

• Pregnant women are ineligible.
• Patients who are unable to follow breathing instructions either due to language difficulties or hearing impairment This will be determined either by one of the consenting individuals when they approach the patient to ask for informed consent or prior to acquisition of the clinical PET/CT.
• Patients who are too ill to hold their breath.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• GE Healthcare: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Heiko Schoder, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (1)