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

December 22, 2024 updated by: Zhang jun, Zhejiang University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province, China.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are clinically suspected or diagnosed with malignant solid tumors.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient Self-Control
Other: 99mTc-FDPH46 SPECT/CT Imaging
99mTc-FDPH46 SPECT/CT Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared with the pathological gold standard, assess the diagnostic efficacy of 99mTc-FDPH46 in malignant solid tumors.
Time Frame: 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.
2024.12-2026.10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the safety, biodistribution, and tumor uptake of 99mTc-FDPH46 SPECT/CT in patients with malignant solid tumors.
Time Frame: 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.
2024.12-2026.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Collaborators

First Affiliated Hospital of Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 28, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20240134C-R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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