T-NK Cell LymphomaNCT06863441
The Value of PET Imaging Targeting Granzyme B in Predicting Efficacy and Prognosis in T-NK Cell Lymphoma
An observational study of T-NK Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The study on the value of PET imaging targeting granzyme B in predicting the efficacy and prognosis of T-NK cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-NK Cell Lymphoma
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Chinese patient with pathologically confirmed T-NK cell lymphoma
Who may be able to join
- Age > 18 years, regardless of gender.
- Histopathologically confirmed diagnosis of T-NK cell lymphoma.
- Newly diagnosed and untreated patients or refractory/relapsed patients preparing to undergo immunotherapy.
- Availability of complete clinicopathological and follow-up data.
- Signed and dated informed consent form.
Who cannot join
- Patients who have previously received anti-tumor therapy.
- Patients with a history of other malignancies.
- Incomplete clinical information or imaging data.
- Concurrent other malignant tumors.
- Patients with severe medical conditions deemed unsuitable for participation in this clinical study by the investigator, such as severe cardiopulmonary insufficiency or severe hepatic and renal dysfunction.
- Poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School, Shanghai
Shanghai, Shanghai Municipality
Biao Li, 13661777388, lb10363@rjh.com.cn
About this study
The study on the value of PET imaging targeting granzyme B in predicting the efficacy and prognosis of T-NK cell lymphoma.
Read the detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy.
- Conditions
- T-NK Cell Lymphoma
- Keywords
- PET/CT, Granzyme B, immunotherapy
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lipodystrophy, Congenital Generalized
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 diagnosed with T-NK cell lymphoma who will receive immunotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Measured: Baseline and 7-10 days after treatment
Secondary outcomes (2)
Progress free suivival
Progress free suivival
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-NK Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI BIAO, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863441
- Sponsor's protocol ID
- RuijinH 2025-34
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of PET Imaging Targeting Granzyme B in Predicting Efficacy and Prognosis in T-NK Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06863441
- Acronym / sponsor ID
- RuijinH 2025-34
- Conditions
- T-NK Cell Lymphoma
- Keywords
- PET/CT, Granzyme B, immunotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Mar 2025 (actual)
- 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.
The study on the value of PET imaging targeting granzyme B in predicting the efficacy and prognosis of T-NK cell lymphoma.
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with T-NK cell lymphoma who will receive immunotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patient with pathologically confirmed T-NK cell lymphoma
Key inclusion criteria (5 listed)
- Age > 18 years, regardless of gender.
- Histopathologically confirmed diagnosis of T-NK cell lymphoma.
- Newly diagnosed and untreated patients or refractory/relapsed patients preparing to undergo immunotherapy.
- Availability of complete clinicopathological and follow-up data.
- Signed and dated informed consent form.
Key exclusion criteria (6 listed)
- Patients who have previously received anti-tumor therapy.
- Patients with a history of other malignancies.
- Incomplete clinical information or imaging data.
- Concurrent other malignant tumors.
- Patients with severe medical conditions deemed unsuitable for participation in this clinical study by the investigator, such as severe cardiopulmonary insufficiency or severe hepatic and renal dysfunction.
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
Standardized uptake value (SUV)
Time frame: Baseline and 7-10 days after treatment
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
2 secondary outcomes
Progress free suivival
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 T-NK Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
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 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: opening soon, as of the sponsor's last update on 7 Mar 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Zhang (15958022176, zhangxinyu76@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: Baseline and 7-10 days after treatment). 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 7 Mar 2025.