Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhejiang University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients who are clinically suspected or diagnosed with malignant solid tumors.
Ages between 18 to 80 years old.
Stable vital signs, ECOG score of 0-2, capable of tolerating and cooperating with the 99mTc-FDPH46 SPECT/CT examination.
Subjects who are willing to undergo the 99mTc-FDPH46 SPECT/CT examination and have signed the informed consent form.
Disqualifiers
Those who can not understand, comply with the research protocol or are unable to sign the informed consent form.
Contraindications for SPECT imaging (including pregnant women, nursing women, women of childbearing age with recent plans to conceive, etc.).
Unstable vital signs, ECOG score >2, unable to tolerate or cooperate with the 99mTc-FDPH46 SPECT/CT examination process.
Trial population
Patients who are clinically suspected or diagnosed with malignant solid tumors.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
99mTc-FDPH46 SPECT/CT Imaging
Other intervention99mTc-FDPH46 SPECT/CT Imaging
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patient Self-Control1 intervention
Trial outcomes
Primary outcomes
1
Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors.
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.
Time frame
2024.12-2026.10Secondary outcomes
1
Assess the safety, biodistribution, and tumor uptake of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors.
Assess the safety of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors, recording any adverse reactions such as nausea, vomiting, and damage to liver and kidney functions; meanwhile, use the standardized uptake value (SUV) for a quantitative analysis of the tracer's biodistribution and tumor uptake in the patients' bodies.
Time frame
2024.12-2026.12Sponsors and contacts
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Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: