Benefits Study of Respiratory-gated Positron Emission Tomography Acquisitions of the Liver

NCT01219985 | Completed Results

• 2 other identifiers: PI07-PR-MEYER22007-A01343-50
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion and because the liver is intrinsically FDG avid, some tumours (especially the smallest ones) can be occulted and missed by the clinician. The investigators developed a respiratory-gated PET method in order to reduce the motion issue. This protocol has been validated on lung pathologies. The investigators designed a study to investigate its effect on liver cancer (primary or metastasis) to check if it allows the detection of a higher number of tumour lesions. To that aim, patients who are planned to undergo a surgical intervention on the liver can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (\~10s) CT is performed.

Conditions

Liver Cancer

Keywords

positron emission tomography / computed tomography; 18F-fluoro-2-deoxyglucose; liver neoplasm; respiratory motion

Outcome Measures

Primary Outcomes (1)

• Number of Detected Uptakes on PET Images

  Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).

  day 1

Secondary Outcomes (1)

• Lesions Uptake Measurement (SUVmax)

  Day 1

Study Arms (1)

Investigation arm

EXPERIMENTAL

"standard and respiratory-gated PET acquisitions " for patients included in the trial.

Other: standard and respiratory-gated PET acquisitions

Interventions

standard and respiratory-gated PET acquisitions OTHER

After fasting for at least 6 hours, normal glucose blood level was checked and each patient received an intravenous injection of 18F-FDG (5MBq/kg). After a 60-minute uptake phase in a quiet environment, patients underwent the PET/CT examination. * Whole-body PET/CT (Ungated session) The Ungated acquisition consisted in a whole-body, free-breathing CT followed by standard multistep PET, used as routine clinical practice in the department. * Respiratory-gated PET/CT (CT-based session) The CT-based method consisted in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations.

Also known as: Biograph™, Siemens medical solutions, Anzai medical, Cisbio

Investigation arm

Eligibility Criteria

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

You may qualify if:

• patient planed to undergo any liver surgical intervention
• age : over 18
• patients gave their written informed consent

You may not qualify if:

• pregnancy
• liver surgical intervention cancel upon surgical or medical decision

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

centre hospitalier universitaire d'Amiens

Amiens, Picardy, 80054, France

Location

Related Publications (2)

• Fin L, Daouk J, Bailly P, Slama J, Morvan J, El Esper I, Regimbeau JM, Chatelain D, Diouf M, Meyer ME. Improved imaging of intrahepatic colorectal metastases with 18F-fluorodeoxyglucose respiratory-gated positron emission tomography. Nucl Med Commun. 2012 Jun;33(6):656-62. doi: 10.1097/MNM.0b013e328351fce8.

  PMID: 22382308 RESULT

• Daouk J, Fin L, Bailly P, Slama J, Diouf M, Morvan J, El Esper I, Regimbeau J-M, Chatelain D, Meyer M-E. The Benefits of Respiratory Gating in 18F-FDG PET Imaging of the Liver, The International Journal of Nuclear Energy Science and Engineering 2(1):5-10, 2012

  RESULT

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Pr. Marc-Etienne Meyer
• Organization: Centre Hospital-Universitaire d'Amiens

meyer.marc-etienne@chu-amiens.fr

+33 3 22 45 59 64

Study Officials

• Marc-Etienne Meyer, Pr

  CHU Amiens

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: May 27, 2016
• Results First Posted: October 10, 2013

Record last verified: 2016-04

Locations

FR (1)