Solid TumorPhase 2NCT07107633
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 Phase 2 study testing Technetium [99mTc]-H7ND injection in people with Solid Tumor and Peritoneal Metastasis, run by Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Peritoneal Metastasis
- What is being tested?
- Technetium [99mTc]-H7ND injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to Sep 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai
Hongcheng Shi, 021-64041990, shi.hongcheng@zs-hospital.sh.cn
About this study
Official title: 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.
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
- Being tested
- Technetium [99mTc]-H7ND injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium [99mTc]-H7ND injectionDrug
Technetium [99mTc]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignant tumors of the gastrointestinal tract | Experimental | Not described Receives: Drug: Technetium [99mTc]-H7ND injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-7 days from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start12 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107633
- Sponsor's protocol ID
- 2025-024R
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07107633
- Acronym / sponsor ID
- 2025-024R
- Conditions
- Solid Tumor, Peritoneal Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.University, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant tumors of the gastrointestinal tract | Experimental | Drug: Technetium [99mTc]-H7ND injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technetium [99mTc]-H7ND injectionTechnetium [99mTc]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor | Drug | Patients with malignant tumors of the gastrointestinal tract |
Primary outcome
To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor
Time frame: 1-7 days from time of injection
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Technetium [99mTc]-H7ND injection in people with Solid Tumor and Peritoneal Metastasis, run by Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongcheng Shi (021-64041990, shi.hongcheng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of technetium [99mTc]-H7ND injection in the diagnosis of peritoneal metastasis of gastrointestinal malignant tumor (time frame: 1-7 days from time of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.