Aggressive LymphomaNCT07657494
Predictive Value of Tumor Microenvironment PET/CT for Response and Prognosis in Aggressive Lymphoma
A study testing Al18F-NOTA-FAPI and Al18F-NOTA-grazytracer/68Ga-grazytracer in people with Aggressive Lymphoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This multicenter study aims to evaluate the predictive value of tumor microenvironment PET/CT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET/CT imaging, and selected patients who are candidates… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive Lymphoma
- What is being tested?
- Al18F-NOTA-FAPI and Al18F-NOTA-grazytracer/68Ga-grazytracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Histologically confirmed aggressive lymphoma.
- Baseline PET/CT showing moderate to high FDG uptake in lymphoma lesions.
- No previous history of malignant tumors.
- No significant cardiac, hepatic, or renal dysfunction.
- Expected survival of at least 6 months and ability to complete follow-up.
Who cannot join
- Low FDG uptake on baseline PET/CT.
- Lymphoma lesions have been surgically removed, with no positive lesions available for evaluation.
- Active or uncontrolled chronic inflammation or infection.
- Uncontrolled diabetes mellitus.
- Incomplete clinical data or loss to follow-up.
- Refusal to sign the informed consent form.
- Inability to lie supine for 30 minutes.
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, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chao Yang, 100021
Xin Liu, M.D., 15621479631, liux0077@163.com
About this study
Official title: The Predictive Value of Tumor Microenvironment PET/CT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study
This multicenter study aims to evaluate the predictive value of tumor microenvironment PET/CT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET/CT imaging, and selected patients who are candidates for immunotherapy will undergo Grazytracer PET/CT imaging. These imaging methods are intended to assess fibroblast activation protein expression and granzyme B activity in lymphoma lesions, reflecting cancer-associated fibroblasts and cytotoxic T-cell activity in the tumor microenvironment. The study will explore optimal imaging assessment criteria and develop clinical-pathological-imaging models to predict treatment response, prognosis, and the relationship between tumor heterogeneity and refractory or relapsed disease.
- Conditions
- Aggressive Lymphoma
- Being tested
- Al18F-NOTA-FAPI, Al18F-NOTA-grazytracer/68Ga-grazytracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-NOTA-FAPIDrug
Al18F-NOTA-FAPI was injected into the patients before the PET/CT scans
Al18F-NOTA-grazytracer/68Ga-grazytracerDrug
Al18F-NOTA-grazytracer/68Ga-grazytracer was injected into the patients before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| Tumor Microenvironment PET/CT Imaging | Experimental | Participants with aggressive lymphoma will undergo tumor microenvironment PET/CT imaging, including FAPI PET/CT. Participants who are candidates for immunotherapy may also undergo Grazytracer PET/CT. Imaging parameters will be analyzed to evaluate their predictive value for treatment response and prognosis. Receives: Drug: Al18F-NOTA-FAPI; Drug: Al18F-NOTA-grazytracer/68Ga-grazytracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression
The predictive performance of FAPI PET/CT imaging parameters for treatment response or disease progression in patients with aggressive lymphoma will be evaluated. Imaging parameters, including visual assessment and semi-quantitative parameters such as SUVmax, tumor-to-background ratios, metabolic tumor volume, total lesion glycolysis, and SUV heterogeneity, will be analyzed using receiver operating characteristic curve analysis. The area under the curve, sensitivity, specificity, positive predictive value, and negative predictive value will be calculated.
Measured: Every 3 months after enrollment for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start11 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive LymphomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuejuan Wang, M.D., Study chair, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657494
- Sponsor's protocol ID
- NCC012236
- Status last verified
- May 2026
- First submitted
- 14 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Tumor Microenvironment PET/CT Imaging for Treatment Response and Prognosis in Aggressive Lymphoma: A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07657494
- Acronym / sponsor ID
- NCC012236
- Conditions
- Aggressive Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (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.
This multicenter study aims to evaluate the predictive value of tumor microenvironment PET/CT imaging for treatment response and prognosis in patients with aggressive lymphoma. Eligible patients with histologically confirmed aggressive lymphoma will undergo FAPI PET/CT imaging, and selected patients who are candidates for immunotherapy will undergo Grazytracer PET/CT imaging. These imaging methods are intended to assess fibroblast activation protein expression and granzyme B activity in lymphoma lesions, reflecting cancer-associated fibroblasts and cytotoxic T-cell activity in the tumor microenvironment. The study will explore optimal imaging assessment criteria and develop clinical-pathological-imaging models to predict treatment response, prognosis, and the relationship between tumor heterogeneity and refractory or relapsed disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor Microenvironment PET/CT Imaging | Experimental | Drug: Al18F-NOTA-FAPI, Drug: Al18F-NOTA-grazytracer/68Ga-grazytracerParticipants with aggressive lymphoma will undergo tumor microenvironment PET/CT imaging, including FAPI PET/CT. Participants who are candidates for immunotherapy may also undergo Grazytracer PET/CT. Imaging parameters will be analyzed to evaluate their predictive value for treatment response and prognosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed aggressive lymphoma.
- Baseline PET/CT showing moderate to high FDG uptake in lymphoma lesions.
- No previous history of malignant tumors.
- No significant cardiac, hepatic, or renal dysfunction.
- Expected survival of at least 6 months and ability to complete follow-up.
Key exclusion criteria (7 listed)
- Low FDG uptake on baseline PET/CT.
- Lymphoma lesions have been surgically removed, with no positive lesions available for evaluation.
- Active or uncontrolled chronic inflammation or infection.
- Uncontrolled diabetes mellitus.
- Incomplete clinical data or loss to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Al18F-NOTA-FAPIAl18F-NOTA-FAPI was injected into the patients before the PET/CT scans | Drug | Tumor Microenvironment PET/CT Imaging |
| Al18F-NOTA-grazytracer/68Ga-grazytracerAl18F-NOTA-grazytracer/68Ga-grazytracer was injected into the patients before the PET/CT scans | Drug | Tumor Microenvironment PET/CT Imaging |
Primary outcome
Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression
Time frame: Every 3 months after enrollment for up to 2 years
The predictive performance of FAPI PET/CT imaging parameters for treatment response or disease progression in patients with aggressive lymphoma will be evaluated. Imaging parameters, including visual assessment and semi-quantitative parameters such as SUVmax, tumor-to-background ratios, metabolic tumor volume, total lesion glycolysis, and SUV heterogeneity, will be analyzed using receiver operating characteristic curve analysis. The area under the curve, sensitivity, specificity, positive predictive value, and negative predictive value will be calculated.
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 Oct 2026.
- 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.
Xuejuan Wang, M.D. study chair
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Al18F-NOTA-FAPI and Al18F-NOTA-grazytracer/68Ga-grazytracer in people with Aggressive Lymphoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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 Xin Liu, M.D. (15621479631, liux0077@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance of FAPI PET/CT for Treatment Response or Disease Progression (time frame: Every 3 months after enrollment for up to 2 years). 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 Oct 2026.