Clinical trial of 64Cu-DOTA Rituximab, a new radioisotope drug for Positron Emission Tomography for the diagnosis of non-Hodgkin's lymphoma

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0007035
• Lead Sponsor: Korea Institute of Radiological & Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

# Non-Hodgkin lymphoma patients
1. Histologically diagnosed CD-20 positive B-cell non-Hodgkin's lymphoma
- At least one measurable lesion
2. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance
3, Subjects with age =/> 19 years
4. ECOG (Eastern Cooperative Oncology Group) Performance scale =2
5. The life expectancy of greater than or equal to 12 months.
6. Those who satisfy the following conditions in a blood test
- Absolute neutrophil count (ANC) = 1,500/µL
- Platelet count (PLT) = 100,000 / µL
- Blood Urea Nitrogen (BUN) and serum creatine < 1.5 x upper normal limit (ULN)
- AST (aspartate transaminase) and ALT (alanine aminotransferase) < 5 x upper normal limit (ULN)
7. In the case of patients who have recently received chemotherapy, radiation therapy, immunosuppressive drugs, or cytokine therapy, those who have passed 4 weeks or more from the date of last administration or irradiation

Exclusion Criteria

1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition
2. The person who is determined to have a mental disorder that is difficult to perform PET (Positron Emission Tomography) scan
3. Pre-menopausal women who are pregnant or lactating at screening, or planning to become pregnant during the clinical trial period
4. Those who are participating in other clinical trials at screening and whose clinical trials may affect the acquisition of 18F-FDG or 64Cu-DOTA-Rituximab PET images during screening (e.g., simply follow-up not receiving investigational drugs at screening If you are participating in other cohort clinical trials, you can participate in the current clinical trial)
5. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-FDG or 64Cu-DOTA-Rituximab PET (Positron Emission Tomography) images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 18F-FDG or 64Cu-DOTA-Rituximab (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials.)
6. Those who have the potential to influence the acquisition of 18F-FDG PET images due to unadjusted diabetes
7. Any other person who is deemed not to be eligible to participate in the trial
8. Vulnerable subjects (researchers or students who participated in the research, family members, researchers or students of researchers participating in research)
9. Subject with obstructive hydronephrosis
10. Subject with infections requiring intravenous antibiotic treatment
11. HAMA (Human Anti-murine Antibody) positive

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) of lymphoma lesion in 64Cu-DOTA-Rituximab PET

Secondary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) of blood pool, bladder, liver, and spleen in 64Cu-DOTA-Rituximab PET