Dual Time Point PET in Lymphoma

July 9, 2013 updated by: Karen Juul Mylam, Odense University Hospital

This study aims to investigate the value of dual time point PET/CT in lymphoma. Since FDG uptake is linked to glucose metabolism, PET imaging is also used to detect suspected sites for infectious and inflammatory disorders. In a clinical setting, it is a challenge to distinguish between FDG uptake in benign and malignant lesions and this gives rise to a considerable quantity of false positive results and decreased positive predictive values. Performing FDG-PET imaging sixty minutes after injection is common practice in the staging and surveillance of lymphoma but this procedure may not be optimal, especially not in settings where benign inflammatory lesions are of clinical concern.

In an attempt to find an alternative method for this discrimination, dual time point FDG-PET was introduced. This technique has shown itself to be a potentially promising method in FDG-PET imaging for distinguishing between malignant and benign lesions using SUV values. The reason for the different FDG uptake patterns between inflammatory and malignant lesions is unclear. Several factors may contribute to this phenomenon on a cellular basis. It has been shown that cancer cells exhibit increased numbers of glucose transporter and low level of glucose-6-phosphatase. Varying levels between different cancer cell types may explain the different FDG uptake curves. Because various cell types exhibit varying rates of FDG uptake we believe that kinetic investigation may prove to be of value in understanding different types of lymphoma and identifying how to perform precise imaging for staging and surveillance.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital, Department of hematology
        • Contact:
        • Principal Investigator:
          • Karen Juul Mylam, MD
      • Roskilde, Denmark, 4000
        • Not yet recruiting
        • Roskilde Hospital
        • Contact:
        • Sub-Investigator:
          • Lars Møller Pedersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed NHL and HL

Description

Inclusion Criteria:

  • Age>18 years
  • Planned for curative treatment

Exclusion Criteria:

  • Previously treatment with chemotherapy or irradiation
  • Primary CNS lymphoma
  • Recurrent lymphoma
  • Transformation from indolent lymphoma
  • Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with suspected lymphoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 2 years
To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome.
2 years
Progression free survival
Time Frame: 3 years
To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years, 3 years
To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome.
2 years, 3 years

Other Outcome Measures

Outcome Measure
Time Frame
To compare SUVmax with the expression of GLUT1, hexokinase, G6Pase in lymphoma cells
Time Frame: 1 day (After diagnostic biopsy)
1 day (After diagnostic biopsy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.06b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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