Patients with lymphoma (diffuse large B-cell lymphoma, chronic lymphoma, follicular lymphoma, mantle cell lymphoma) or ROR1-positive solid tumors (including but not limited to ovarian cancer, triple negative breast cancer)
Conditions
Interventions
100~200 MBq(2.7~5.4 mCi) Group:68Ga-ROR1-P Injection
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years (including 18 and 75 years), male or female; 2.Patients with clinically confirmed lymphomas (e.g., diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, etc.) or ROR1-positive solid tumors (including but not limited to ovarian cancer, triple negative breast cancer); 3.Past pathological samples may be provided or there is no contraindication to puncture biopsy or surgery, and there is no contraindication to anesthesia; 4.For women of childbearing potential, a negative pregnancy test within 72 hours prior to study drug administration and consent to use non-hormonal methods of contraception for at least 4 weeks after receiving study drug. For men, agree to use contraception for at least 4 weeks after receiving study drug; 5.Able to understand and comply with the procedures and requirements of this study and voluntarily sign the informed consent form, have no contraindications to examination, and have the ability and willingness to participate in the follow-up plan.
Exclusion criteria
Exclusion criteria: 1.Important organ dysfunction, such as severe liver and kidney dysfunction; 2.Patients with a second primary malignancy prior to enrollment, except for those with a low risk of metastasis and death, and have been cured (5-year survival rate > 90%), such as nonmetastatic basal cell or superficial squamous cell carcinoma of the skin, low-grade superficial bladder cancer, etc. 3.Unable to obtain previous pathological results, or insufficient sample size of available pathological tissue, poor sample quality, inadmissible sampling in physical condition, limitations in pathological techniques, etc. 4.Received the following treatments prior to dosing: a) Received radionuclide diagnostic or therapeutic drugs prior to dosing, with no more than 10 physical half-lives from the last dose. b) Use of any intravenous iodinated contrast agent within 24 hours prior to dosing or any high-density oral contrast agent (oral aqueous contrast is acceptable) within 5 days prior to dosing. c) Receive anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, etc.) within 28 days prior to dosing. d) Enrollment is less than 12 weeks from the most recent surgical treatment. If the patient has recovered from surgery before enrollment and meets other eligibility criteria, it can be relaxed to 8 weeks at the discretion of the investigator (except for procedures related to non-therapeutic purposes, such as needle biopsy, etc.); 5.Toxicities due to prior anti-tumor therapy have not recovered to = Grade 1 according to NCI-CTCAE v5.0 (with the exception of lymphocyte count decreased alone, alopecia, and indicators already mentioned in the enrollment criteria; at the discretion of the investigator, partial tolerated chronic Grade 2 toxicities may be excluded after consultation with the investigator). 6.Any factors that do not allow the PET examination to proceed smoothly or interfere with the interpretation of the imaging results, including but are not limited to the following: e.g., inability to lie down, rest, or tolerate a PET scan. 7.Known allergy, hypersensitivity, or contraindications to multiple drugs or foods, including the investigational drug or any component of its formulation; 8.Participating in other clinical studies or dosing less than 4 weeks from the end of the last dose in the previous clinical study. 9.According to the investigator, the subject has other factors that may lead to the subject being forced to discontinue the study, such as non-compliance with the protocol, other serious diseases (including psychiatric disorders) requiring concomitant therapy, clinically significant abnormal laboratory values, family or social factors, which may affect the safety of the subject or the collection of study data, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SUVmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE/SAE; | — |
Countries
China
Contacts
Public ContactBin Zhang
The First Affiliated Hospital of Soochow University
Outcome results
None listed