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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01894945
Other study ID # 10.06b
Secondary ID
Status Recruiting
Phase N/A
First received July 4, 2013
Last updated July 9, 2013
Start date March 2012
Est. completion date July 2014

Study information

Verified date July 2013
Source Odense University Hospital
Contact Karen Juul Mylam, MD
Phone 0045 6541 3186
Email karen.mylam@rsyd.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Odense University Hospital, Department of hematology Odense
Denmark Roskilde Hospital Roskilde

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other To compare SUVmax with the expression of GLUT1, hexokinase, G6Pase in lymphoma cells 1 day (After diagnostic biopsy) No
Primary Progression Free Survival To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome. 2 years No
Primary Progression free survival To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome. 3 years No
Secondary Overall survival To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome. 2 years, 3 years No