A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET… (NCT06925958) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET Imaging and Histological Expression of 68Ga-NOTA-SCH001 in Patients With Multiple Myeloma
15 participantsStarted 2025-05-01
Plain-language summary
Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has become a prerequisite for pre- and post-treatment evaluation. CD38, which is abnormally elevated in 95% to 100% of malignant plasma cells but relatively low in normal cells, serves as a biomarker for multiple myeloma. In clinical practice, CD38 expression is typically detected through flow cytometry and microscopic examination of bone marrow biopsy samples. However, biopsies are invasive and prone to false-negative results in cases of heterogeneity or small lesion samples, whereas whole-body imaging methods allow non-invasive assessment of target expression.
\[¹⁸F\]FDG PET/CT imaging is one of the most commonly used techniques in multiple myeloma. However, its diagnostic application is limited by false-negative results due to low hexokinase 2 expression in myeloma cells. Additionally, it fails to provide accurate molecular information, such as CD38 expression in cells. Therefore, this study aims to develop a more specific and stable molecular imaging probe, ⁶⁸Ga-NOTA-SCH001, to non-invasively visualize CD38 expression and monitor responses to CD38-targeted therapy in real time. This approach may also contribute to the formulation and optimization of clinical treatment strategies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
2\. Over 18 years old, male or female;
3\. Patients diagnosed with multiple myeloma;
4\. ECOG score is 0-1; The expected survival time is not less than 3 months;
5\. Women of childbearing age need to undergo urine pregnancy test, and enrolled patients must be negative for pregnancy test;
6\. For fertile female patients or male patients with fertile partners, agree to remain abstinent during the study period (no
Or use one or more contraceptive methods with a failure rate of less than 1% per year for at least one year after the end of the study.
7\. CD38 monoclonal antibody therapy was not used before enrollment in this study.
Exclusion Criteria:
* General situation
* Those who are unable to perform visits, or receive relevant tests, or treatment in accordance with the clinical trial protocol;
* Can not tolerate venous puncture blood collection;
* Patients with serious diseases or other malignant tumors, except those that the researchers determined to be in stable control;
* Known severe allergy to SCH001, similar drugs or excipients;
Laboratory examination
• Serum virology test: any of the results of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis specific antibodies
Positive or HIV-negative antibodies cannot be determined;
• Fasting blood glucose \>11.1mmol/L;
other
* No act…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PET/CT imaging SUV value
Timeframe: 0-30minutes、60minutes、120minutes
Trial details
NCT IDNCT06925958
SponsorThe First Affiliated Hospital of Soochow University