The goal of this observational study aims to preliminarily evaluate the diagnostic efficacy of 99mTc-FDPH46 SPECT/CT in malignant solid tumors (compared to the pathological gold standard). The main questions it aims to answer are:
* What is the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors, compared to the pathological gold standard?
* What is the biodistribution, tumor uptake and safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors?
Participant Will:
• Patients with clinically suspected or diagnosed malignant solid tumors who are willing to undergo 99mTc-FDPH46 SPECT/CT examination and sign an informed consent form.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients who are clinically suspected or diagnosed with malignant solid tumors.
2. Ages between 18 to 80 years old.
3. Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
4. Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.
Exclusion Criteria:
1. Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.
2. Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
3. Unstable vital signs, ECOG score \>2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.
Primary outcome measure(s)
Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors. — 2024.12-2026.10 Using the pathological gold standard as a reference, the sensitivity, specificity, positive predictive value, and negative predictive value of 99mTc-FDPH46 in patients with malignant solid tumors were evaluated. The consistency between the two diagnostic methods was assessed by Kappa analysis, thereby determining the diagnostic efficacy of 99mTc-FDPH46 in patients with malignant solid tumors.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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