Peripheral T Cell LymphomaNCT01470066
Clinical Usefulness and Prognostic Significance of Interim 18F-FDG PET/CT for the Treatment of Peripheral T Cell Lymphomas
An observational study of Peripheral T Cell Lymphoma, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma (DLBCL), the positive predictive value (PPV) of interim PET/CT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2004to May 2012
- 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: This study is the observational study for the response assessments on interim PET/CT during the treatment of peripheral T cell lymphomas. Thus, first analysis of clinical data will be performed at the time of 80 patients enrolled or after a median follow-up of more than 12 months.
Who may be able to join
- Age above 18 years
- Histologically proven PTCLs except primary cutaneous/subcutaneous panniculitis
- ECOG performance status ≤ 2
- Patients who are available to be performed PET/CT at diagnosis
- No severe concomitant disease
Who cannot join
- Patients who did not undergo PET/CT scans at diagnosis
- Patients who have a primary CNS lymphoma
- Patients who have a HIV or HTLV-1
- Patients who could not receive primary chemotherapy
Trial locations and contacts
1 site in 1 country.
Je-Jung Lee, M.D.,Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 519-809
So-Young Lee, Nurse, 82-61-379-7628, kaosin@naver.com
Deok-Hwan Yang, M.D.,Ph.D.
About this study
Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT will be prospectively investigated to determine whether it provided additional prognostic information and could be a positive predictable value for the treatment of PTCL.
Read the detailed description
- Treatment protocol
- Patients with limited-stage (stage I/II) are treated with CHOP/CHOP-like chemotherapy [cyclophosphamide 750 mg/m2 i.v. on D1, vincristine 1.4 mg/m2 i.v. on D1, doxorubicin 50 mg/m2 i.v. on D1, and prednisolone 60 mg/m2 p.o. on D1-5] in standard doses every three weeks and three to four cycles of CHOP/CHOP-like chemotherapy followed by involved field radiation therapy (IFRT, 30 Gy). Patients with advanced-stage (stage III/IV) are treated with eight cycles of primary chemotherapy and patients greater than 65 years and/or those with a frail general condition were treated with only six cycles of primary chemotherapy if they achieved a complete response (CR) for the interim response.
- Response evaluation based on three parameters of visual, standard uptake value(SUV)-based and metabolic tumor volume (MTV)-based assessments
- We firstly classify patients with five-point scale (5-PS) by the interim PET/CT analysis based on the Deauville criteria12: 1, No uptake; 2, uptake ≤ mediastinum; 3, uptake > mediastinum but ≤ liver; 4, uptake moderately increased compared to the liver uptake at any site; 5, markedly increased uptake compared to the liver at any site and new sites or/and new sites of disease. Interim PET/CT image are graded as negative or positive by comparison of initial PET/CT and grade 1-3 considered as negative and grade 4-5 considered for positive.19 This grading process is independent of the size of the residual tumor. Secondly, we classify the patients with the quantitative analysis of 18F-FDG uptake changes based on the percentage of SUVmax reduction between initial and interim PET/CT. On axial, coronal, or sagittal coregistered PET/CT slices, simple circular regions of interest (ROIs) were placed so as to cover the lesion or background. SUV measurements are corrected for body weight according to the following standard formula: Mean ROI activity (MBq/ml)
- [Injected dose (MBq)/Body weight (kg)].20 For each PET dataset, the maximum SUV (SUVmax) is defined as the highest SUV among all hypermetabolic tumor foci. SUVmax reduction rate (ΔSUVmax) is calculated as following: ΔSUVmax (%) = 100 x [SUVmax (initial) - SUVmax (interim)]/SUVmax (initial) If all lesions had disappeared on interim PET, ROI were drawn in the same area on interim PET as on baseline PET. We finally classify the patients with the quantitative analysis of metabolic volume changes based on the percentage of MTV reduction (ΔMTV) between initial and interim PET/CT. To define the exact tumor margins around the target lesions, SUV2.5 is used as following previous reports, which means that the tumor volume area in PET/CT is delineated by a circle encompassing regions with SUV cutoff value of 2.5.16,21 The MTV2.5 is measured using AW Volume ShareTM workstation (GE Healthcare) on the fused PET/CT images.17 AW Volume ShareTM allows automatic registration and fusion between two volumetric acquisitions, which come from different acquisition modalities. The active MTV2.5 are measured in a 3-D manner by selecting volume of interest (VOI) on the axial image, and the size of VOI is manually regulated on the corresponding coronal and sagittal images to include entire active tumors in the VOI. The SUVmax and the sum of the tumor volumes in all hypermetabolic tumor foci were computed automatically by the program. The MTV2.5 reduction rate (ΔMTV2.5) is calculated as same formula as SUVmax reduction rate.
- The response assessments of interim PET/CT scans
- will be assessed based on the combination with three parameters of the Deauville five-point scale (5-PS), the reduction rate of maximal standardized uptake value (ΔSUVmax), and the reduction rate of metabolic tumor volume (ΔMTV2.5) in PTCLs
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- peripheral T cell lymphomas, interim PET/CT, prognosis, Positron-emission tomography/Computerized tomography
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Patients whose disease did not progress would be censored using the date at which they were last known to show no progress.
Measured: From the treatment start time to the first recording of disease progression or death from any cause, which assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startAug 2004
- Primary completionMay 2010
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470066
- Sponsor's protocol ID
- PET2005-01
- Status last verified
- Sep 2005
- First submitted
- 3 Nov 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jung SH, Ahn JS, Kim YK, Kweon SS, Min JJ, Bom HS, Kim HJ, Chae YS, Moon JH, Sohn SK, Lee SW, Byun BH, Do YR, Lee JJ, Yang DH. Prognostic significance of interim PET/CT based on visual, SUV-based, and MTV-based assessment in the treatment of peripheral T-cell lymphoma. BMC Cancer. 2015 Mar 28;15:198. doi: 10.1186/s12885-015-1193-1.
PubMed 25879747
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness and Prognostic Significance of Interim 18F-FDG PET/CT for the Treatment of Peripheral T Cell Lymphomas
- ClinicalTrials.gov ID
- NCT01470066
- Acronym / sponsor ID
- PET2005-01
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- peripheral T cell lymphomas, interim PET/CT, prognosis, Positron-emission tomography/Computerized tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Study start
- Aug 2004
- Primary completion
- May 2010 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 11 Nov 2011 (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.
Although interim 18F-fluoro-2-deoxy-D-glucose-positron emission tomography (FDG-PET)/computerized tomography (CT) scan has emerged as a powerful prognostic tool in predicting treatment outcome in Hodgkin's lymphoma (HL) and diffuse large B cell lymphoma (DLBCL), the positive predictive value (PPV) of interim PET/CT scanning has not been determined in patients with peripheral T cell lymphoma (PTCL). The sequential interim PET/CT will be prospectively investigated to determine whether it provided additional prognostic information and could be a positive predictable value for the treatment of PTCL.
Detailed description
- Treatment protocol
- Patients with limited-stage (stage I/II) are treated with CHOP/CHOP-like chemotherapy [cyclophosphamide 750 mg/m2 i.v. on D1, vincristine 1.4 mg/m2 i.v. on D1, doxorubicin 50 mg/m2 i.v. on D1, and prednisolone 60 mg/m2 p.o. on D1-5] in standard doses every three weeks and three to four cycles of CHOP/CHOP-like chemotherapy followed by involved field radiation therapy (IFRT, 30 Gy). Patients with advanced-stage (stage III/IV) are treated with eight cycles of primary chemotherapy and patients greater than 65 years and/or those with a frail general condition were treated with only six cycles of primary chemotherapy if they achieved a complete response (CR) for the interim response.
- Response evaluation based on three parameters of visual, standard uptake value(SUV)-based and metabolic tumor volume (MTV)-based assessments
- We firstly classify patients with five-point scale (5-PS) by the interim PET/CT analysis based on the Deauville criteria12: 1, No uptake; 2, uptake ≤ mediastinum; 3, uptake > mediastinum but ≤ liver; 4, uptake moderately increased compared to the liver uptake at any site; 5, markedly increased uptake compared to the liver at any site and new sites or/and new sites of disease. Interim PET/CT image are graded as negative or positive by comparison of initial PET/CT and grade 1-3 considered as negative and grade 4-5 considered for positive.19 This grading process is independent of the size of the residual tumor. Secondly, we classify the patients with the quantitative analysis of 18F-FDG uptake changes based on the percentage of SUVmax reduction between initial and interim PET/CT. On axial, coronal, or sagittal coregistered PET/CT slices, simple circular regions of interest (ROIs) were placed so as to cover the lesion or background. SUV measurements are corrected for body weight according to the following standard formula: Mean ROI activity (MBq/ml)
- [Injected dose (MBq)/Body weight (kg)].20 For each PET dataset, the maximum SUV (SUVmax) is defined as the highest SUV among all hypermetabolic tumor foci. SUVmax reduction rate (ΔSUVmax) is calculated as following: ΔSUVmax (%) = 100 x [SUVmax (initial) - SUVmax (interim)]/SUVmax (initial) If all lesions had disappeared on interim PET, ROI were drawn in the same area on interim PET as on baseline PET. We finally classify the patients with the quantitative analysis of metabolic volume changes based on the percentage of MTV reduction (ΔMTV) between initial and interim PET/CT. To define the exact tumor margins around the target lesions, SUV2.5 is used as following previous reports, which means that the tumor volume area in PET/CT is delineated by a circle encompassing regions with SUV cutoff value of 2.5.16,21 The MTV2.5 is measured using AW Volume ShareTM workstation (GE Healthcare) on the fused PET/CT images.17 AW Volume ShareTM allows automatic registration and fusion between two volumetric acquisitions, which come from different acquisition modalities. The active MTV2.5 are measured in a 3-D manner by selecting volume of interest (VOI) on the axial image, and the size of VOI is manually regulated on the corresponding coronal and sagittal images to include entire active tumors in the VOI. The SUVmax and the sum of the tumor volumes in all hypermetabolic tumor foci were computed automatically by the program. The MTV2.5 reduction rate (ΔMTV2.5) is calculated as same formula as SUVmax reduction rate.
- The response assessments of interim PET/CT scans
- will be assessed based on the combination with three parameters of the Deauville five-point scale (5-PS), the reduction rate of maximal standardized uptake value (ΔSUVmax), and the reduction rate of metabolic tumor volume (ΔMTV2.5) in PTCLs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is the observational study for the response assessments on interim PET/CT during the treatment of peripheral T cell lymphomas. Thus, first analysis of clinical data will be performed at the time of 80 patients enrolled or after a median follow-up of more than 12 months.
Key inclusion criteria (5 listed)
- Age above 18 years
- Histologically proven PTCLs except primary cutaneous/subcutaneous panniculitis
- ECOG performance status ≤ 2
- Patients who are available to be performed PET/CT at diagnosis
- No severe concomitant disease
Key exclusion criteria (4 listed)
- Patients who did not undergo PET/CT scans at diagnosis
- Patients who have a primary CNS lymphoma
- Patients who have a HIV or HTLV-1
- Patients who could not receive primary chemotherapy
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: From the treatment start time to the first recording of disease progression or death from any cause, which assessed up to 24 months.
Patients whose disease did not progress would be censored using the date at which they were last known to show no progress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2011.
- Derived from this study: PubMed 25879747Jung SH, Ahn JS, Kim YK, Kweon SS, Min JJ, Bom HS, Kim HJ, Chae YS, Moon JH, Sohn SK, Lee SW, Byun BH, Do YR, Lee JJ, Yang DH. Prognostic significance of interim PET/CT based on visual, SUV-based, and MTV-based assessment in the treatment of peripheral T-cell lymphoma. BMC Cancer. 2015 Mar 28;15:198. doi: 10.1186/s12885-015-1193-1.
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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.
Je-Jung Lee, M.D.,Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral T Cell Lymphoma, run by Chonnam National University Hospital at 1 site in South Korea.
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 5 inclusion and 4 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 Deok-Hwan Yang, M.D., Ph.D. (82-61-379-7636, drydh1685@gmail.com), 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: From the treatment start time to the first recording of disease progression or death from any cause, which assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470066, which also lists 1 linked publication.
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 11 Nov 2011.