Treatment monitoring using FDG-PET/CT and FLT-PET/CT in patients with Hodgkin Lymphoma. - PET/CT treatment monitoring in Hodgkin Lymphoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017587-16-GB

Enrollment

Registered

2010-11-04

Start date

2010-12-02

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma

Interventions

Product Name: Fluorodeoxyglucose (18F) Pharmaceutical Form: Solution for injection Product Name: Fluorothymidine Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Males and Females; aged > 18 years (no upper limit) 2.Histological diagnosis of Hodgkin Lymphoma(HL) according to WHO lymphoma classification. 3.Receiving ChlVPP chemotherapy. 4.Performance status (ECOG) 0-2. 5.Able and willing to give written informed consent and to comply with the study protocol procedures Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1.Primary Central Nervous System (CNS) lymphoma. 2.Contraindication to any of the drugs contained in the chemotherapy regimen. 3.Previous or concurrent malignant disease unless basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the patient has been disease-free for more than 2 years. 4.Any other serious active disease that in the opinion of the investigator might preclude the patient from having conventional chemotherapy. 5.Females of child bearing potential must have a negative pregnancy test prior to starting the study. Females must not be pregnant or lactating Females of child bearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last FDG-PET/CT and FLT-PET/CT scans. Note: subjects are not considered of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal 6.Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal objective is to find a method for predicting at the earliest time possible (after receiving only one cycle of chemotherapy) if chemotherapy will work in patients with Hodgkin Lymphoma receiving ChlVPP chemotherapy This study will assess and compare the ability of FDG-PET/CT and FLT-PET/CT imaging in predicting, after only one cycle of treatment, the response of patients to the chemotherapy being administered. This is possible by comparing changes in tumour uptake of glucose by using FDG-PET/CT scans done before treatment, after one cycle and at completion of chemotherapy treatment. Also by assessing changes in tumour cell division by using FLT-PET/CT scans done before treatment, after one cycle and at completion of chemotherapy treatment. The working hypothesis is that it would be possible to use the changes recorded by each modality to predict individual patient response early during treatment and to test whether FLT is better than FDG at predicting this respons;Secondary Objective: 1)To establish criteria for prediction of treatment response using images obtained using FLT-PET/CT during treatment of patients. 2)To establish criteria for prediction of treatment response using images obtained using FDG-PET/CT uptake during treatment of patients. 3)To study the predictive information of FDG and FLT uptake in Hodgkin Lymphoma for treatment response: a)At baseline. b)After the first cycle of chemotherapy. c)At the end of treatment.;Primary end point(s): 1)Changes in tumour FDG uptake from baseline PET/CT (FDG-PET/CT-1) to PET/CT after the first cycle of immunochemotherapy (FDG-PET/CT-2) compared to response after completion of treatment (FDG-PET/CT-3). 2)Changes in tumour FLT uptake between baseline (FLT-PET/CT-1) and after the first cycle of immunochemotherapy (FLT-PET/CT-2) compared to response after completion of treatment (FDG-PET/CT-3). 3)Response assessed by FLT-PET/CT after completion of treatment (FLT-PET/CT-3) compared to FDG	—

Measure

Time frame

Main Objective: The principal objective is to find a method for predicting at the earliest time possible (after receiving only one cycle of chemotherapy) if chemotherapy will work in patients with Hodgkin Lymphoma receiving ChlVPP chemotherapy This study will assess and compare the ability of FDG-PET/CT and FLT-PET/CT imaging in predicting, after only one cycle of treatment, the response of patients to the chemotherapy being administered. This is possible by comparing changes in tumour uptake of glucose by using FDG-PET/CT scans done before treatment, after one cycle and at completion of chemotherapy treatment. Also by assessing changes in tumour cell division by using FLT-PET/CT scans done before treatment, after one cycle and at completion of chemotherapy treatment. The working hypothesis is that it would be possible to use the changes recorded by each modality to predict individual patient response early during treatment and to test whether FLT is better than FDG at predicting this respons;Secondary Objective: 1)To establish criteria for prediction of treatment response using images obtained using FLT-PET/CT during treatment of patients. 2)To establish criteria for prediction of treatment response using images obtained using FDG-PET/CT uptake during treatment of patients. 3)To study the predictive information of FDG and FLT uptake in Hodgkin Lymphoma for treatment response: a)At baseline. b)After the first cycle of chemotherapy. c)At the end of treatment.;Primary end point(s): 1)Changes in tumour FDG uptake from baseline PET/CT (FDG-PET/CT-1) to PET/CT after the first cycle of immunochemotherapy (FDG-PET/CT-2) compared to response after completion of treatment (FDG-PET/CT-3). 2)Changes in tumour FLT uptake between baseline (FLT-PET/CT-1) and after the first cycle of immunochemotherapy (FLT-PET/CT-2) compared to response after completion of treatment (FDG-PET/CT-3). 3)Response assessed by FLT-PET/CT after completion of treatment (FLT-PET/CT-3) compared to FDG

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026