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.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Technetium [99mTc]-H7ND injection

    Drug

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

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Patients with malignant tumors of the gastrointestinal tractExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1-7 days from time of injection

Secondary outcomes

Other outcomes

Sponsors and contacts

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