A Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mtc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignant Tumor.

NCT07107633 | Recruiting Phase 2

• 1 other identifier: 2025-024R
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the effectiveness of technetium \[99mTc\]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor. Objective: To evaluate the safety of technetium \[99mTc\]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor. Objective: To explore the diagnostic threshold of technetium \[99mTc\]-H7ND injection for peritoneal metastasis of gastrointestinal malignant tumor.

Conditions

Solid Tumor; Peritoneal Metastasis

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor

  To evaluate whether the sensitivity of 99mTc-H7ND SPECT/CT in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor is better than that of enhanced CT by SOT.

  1-7 days from time of injection

Study Arms (1)

Patients with malignant tumors of the gastrointestinal tract

EXPERIMENTAL

Drug: Technetium [99mTc]-H7ND injection

Interventions

Technetium [99mTc]-H7ND injection DRUG

Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor

Patients with malignant tumors of the gastrointestinal tract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only those who meet all the following requirements are eligible to join the group:
• Adults over 18 years of age (based on the time when the informed consent form was signed) can be male or female;
• Subjects with gastrointestinal malignant tumor confirmed by histology/cytology;
• Subjects to be surgically removed or explored;
• The estimated survival time is ≥12 weeks;
• Subjects of childbearing age agreed to adopt effective contraceptive measures during the study period;
• Subjects fully understand the purpose, nature, methods and possible adverse reactions of the experiment, voluntarily participate in and sign a written informed consent, and are willing to follow the requirements of the protocol to complete the study.riteria:
• Those who meet one of the following items are not allowed to join the group:
• According to the researcher's judgment, during the screening period, from the imaging examination to the comprehensive real diagnosis information result, the patients were treated with anti-digestive tract tumor;
• symptomatic brain metastases who need treatment;
• Have serious cardiovascular and cerebrovascular diseases;
• There are other contraindications for imaging examination of the research plan, such as claustrophobia;
• Have a history of other malignant tumors;
• Pregnant (pregnancy test positive in screening period) or lactating women;
• Other circumstances that the researcher considers inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Technetium

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Central Study Contacts

Hongcheng Shi

CONTACT

021-64041990; shi.hongcheng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 6, 2025
• Study Start: March 12, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

CN (1)