Hodgkin's and Non-Hodgkin's LymphomaNCT01894945
Dual Time Point PET in Lymphoma
An observational study of Hodgkin's and Non-Hodgkin's Lymphoma, run by Odense University Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's and Non-Hodgkin's Lymphoma
- How many people
- 30 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed NHL and HL
Who may be able to join
- Age>18 years
- Planned for curative treatment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Odense University Hospital, Department of hematology
Odense, 5000
Karen Mylam, MD, 0045 6441 3186, karen.mylam@rsyd.dk
Karen Juul Mylam, MD
- Not yet recruiting
Roskilde Hospital
Roskilde, 4000
Lars Møller Pedersen, MD, lmpn@regionsjaelland.dk
Lars Møller Pedersen, MD
About this study
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.
- Conditions
- Hodgkin's and Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected lymphoma. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome.
Measured: 2 years
Progression free survival
To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome.
Measured: 3 years
Secondary outcomes (1)
Overall survival
To evaluate the predictive value of PET after 60min compared to PET after 180min in terms of outcome.
Measured: 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's and Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Juul Mylam, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894945
- Sponsor's protocol ID
- 10.06b
- Status last verified
- Jul 2013
- First submitted
- 4 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Time Point PET in Lymphoma
- ClinicalTrials.gov ID
- NCT01894945
- Acronym / sponsor ID
- 10.06b
- Conditions
- Hodgkin's and Non-Hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected lymphoma. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed NHL and HL
Key inclusion criteria (2 listed)
- Age>18 years
- Planned for curative treatment
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Overall survival
Time frame: 2 years, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's and Non-Hodgkin's Lymphoma, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Juul Mylam, MD (0045 6541 3186, karen.mylam@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2013.