Gastrointestinal MalignanciesNCT06644274
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies
An observational study of Gastrointestinal Malignancies, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for gastrointestinal malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Malignancies
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 31 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.
Who may be able to join
- Pathological and clinical diagnosis of gastrointestinal malignancies requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines.
- Signed and dated informed consent form.
- Commitment to comply with research procedures and co-operation in the implementation of the full research process.
- The patient is in good general condition with an expected survival of > 6 months.
- aged 18-75 years old.
Who cannot join
- Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Intestinal perforation, complete intestinal obstruction.
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Non-compliant person.
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
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, 200001
Wei Cai, 18917762028, caiwei@shsmu.edu.cn
About this study
This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for gastrointestinal malignancies.
Read the detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
- Conditions
- Gastrointestinal Malignancies
- Keywords
- 68Ga-grazytracer PET/CT, gastrointestinal malignancies, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of gastrointestinal malignancies | Patients diagnosis of gastrointestinal malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the responses to immunotherapy of gastrointestinal malignancies
The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of gastrointestinal malignancies
Measured: up to about 10 weeks
Standardized uptake value(SUV)
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Measured: up to about 10 weeks
Target-to-background ratio(TBR)
68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.
Measured: up to about 10 weeks
Secondary outcomes (2)
Progress free survival
Progress free survival
Measured: 1 years
Overall survival
Overall survival
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start20 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MalignanciesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Jiajia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644274
- Sponsor's protocol ID
- RuijinH 2024-278
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT06644274
- Acronym / sponsor ID
- RuijinH 2024-278
- Conditions
- Gastrointestinal Malignancies
- Keywords
- 68Ga-grazytracer PET/CT, gastrointestinal malignancies, Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 16 Oct 2024 (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.
This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for gastrointestinal malignancies.
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of gastrointestinal malignancies | – | –Patients diagnosis of gastrointestinal malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.
Key inclusion criteria (5 listed)
- Pathological and clinical diagnosis of gastrointestinal malignancies requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines.
- Signed and dated informed consent form.
- Commitment to comply with research procedures and co-operation in the implementation of the full research process.
- The patient is in good general condition with an expected survival of > 6 months.
- aged 18-75 years old.
Key exclusion criteria (4 listed)
- Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Intestinal perforation, complete intestinal obstruction.
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Non-compliant person.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation the responses to immunotherapy of gastrointestinal malignancies
Time frame: up to about 10 weeks
The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of gastrointestinal malignancies
Standardized uptake value(SUV)
Time frame: up to about 10 weeks
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Target-to-background ratio(TBR)
Time frame: up to about 10 weeks
68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.
2 secondary outcomes
Progress free survival
Time frame: 1 years
Overall survival
Time frame: 1 years
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Gastrointestinal Malignancies, run by Ruijin Hospital 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 5 inclusion and 4 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 11 Dec 2024. 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.
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 Jiajia Hu (13524945287, jiajiahu@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the responses to immunotherapy of gastrointestinal malignancies (time frame: up to about 10 weeks). The study lists 3 primary outcomes in all. 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 11 Dec 2024.