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

Not yet recruiting

• Conditions: Malignant Tumors; Solid Tumor Malignancy

• Registration Number: NCT06753513
• Lead Sponsor: Zhejiang University

Brief 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.

Detailed Description

Patients who are clinically assessed as suspected or diagnosed with malignant solid tumors will receive an intravenous injection of 20-25mCi of 99mTc-FDPH46. Whole-body planar scintigraphy will be performed at 10, 30, 90, 150, and 240 minutes post-injection to obtain dynamic biodistribution images. Additionally, 99mTc-FDPH46 SPECT/CT imaging will be conducted 60-90 minutes after the intravenous injection to acquire both whole-body planar scintigraphy and SPECT/CT tomographic fusion images. After the scans are completed, patients will be observed in the waiting room for 1 hour before they are allowed to return.During the follow-up visit after the examination, the researchers will collect the patients' clinical information and any changes in symptoms, and record them in the medical records. All subjects will be followed up once on the same day after the SPECT/CT scan and again one week later.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study Start: 2024-12-28
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Assess the safety, biodistribution, and tumor uptake of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors.	2024.12-2026.12	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.

Trial Locations

Locations (1)

No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province, China.; 🇨🇳 Hangzhou, Zhejiang, China