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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.

A Multicenter, Open-access, Self-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Technetium [99mTc]-H7ND Injection in the Diagnosis of Peritoneal Metastasis of Gastrointestinal Malignancies.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07107633
Enrollment
90
Registered
2025-08-06
Start date
2025-03-12
Completion date
2025-09-30
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Metastasis, Solid Tumor

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.

Interventions

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

Sponsors

Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Only those who meet all the following requirements are eligible to join the group: 1. Adults over 18 years of age (based on the time when the informed consent form was signed) can be male or female; 2. Subjects with gastrointestinal malignant tumor confirmed by histology/cytology; 3. Subjects to be surgically removed or explored; 4. The estimated survival time is ≥12 weeks; 5. Subjects of childbearing age agreed to adopt effective contraceptive measures during the study period; 6. 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: 1. 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; 2. symptomatic brain metastases who need treatment; 3. Have serious cardiovascular and cerebrovascular diseases; 4. There are other contraindications for imaging examination of the research plan, such as claustrophobia; 5. Have a history of other malignant tumors; 6. Pregnant (pregnancy test positive in screening period) or lactating women; 7. Other circumstances that the researcher considers inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor1-7 days from time of injectionTo 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.

Countries

China

Contacts

Primary ContactHongcheng Shi
shi.hongcheng@zs-hospital.sh.cn021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026