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Clinical Trials in China / NCT06753513
Starting soon Observational

Clinical Application of 99mTc-FDPH46 SPECT/CT Imaging in Malignant Solid Tumor: a Prospective Exploratory Study

NCT06753513 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Observational
Started
2024-12-28
Last updated
2024-12-31

Condition(s) studied

Malignant TumorsSolid Tumor Malignancy

Investigational drug(s) / intervention(s)

99mTc-FDPH46 SPECT/CT Imaging

99mTc-FDPH46 SPECT/CT Imaging: 99mTc-FDPH46 SPECT/CT Imaging

Study summary

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.

Trial sites (1)

FacilityCityRegionStatus
No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province, China. Hangzhou Zhejiang

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A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China Recruiting
Physician and Patient Preferences for Cell Therapies in Advanced Solid Tumors Recruiting

Other trials for the same condition

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Correlation Analysis of Gene Characteristics of Malignant Tumors With Prognosis Recruiting
Safety Trial of 68Ga/177Lu-NRT6020 in FAP-Positive Advanced Solid Tumor Patients Recruiting
125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors Starting soon
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Official registry record

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.

View NCT06753513 on ClinicalTrials.gov ↗ ← All trials in China