Positron-Emission TomographyNCT06203574
Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
A study testing [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 in people with Positron-Emission Tomography and Neoplasms, run by Huashan Hospital at 1 site in China.
Trial summary
This study will investigate the safety and preliminary diagnostic efficacy of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Positron-Emission Tomography, Neoplasms
- What is being tested?
- [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18 and 65 years of age and of either sex.
- Patients with colorectal cancer confirmed by puncture or surgical pathology.
- Written informed consent signed by the subject or legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Who cannot join
- Severe hepatic or renal insufficiency;
- Targeted therapy before radiotherapy or PET/CT scan；
- Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range；
- History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai
Yihui Guan, MD, 13764308300 ext. +86, guanyihui@hotmail.com
About this study
This study will investigate the safety and preliminary diagnostic efficacy of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.
- Conditions
- Positron-Emission Tomography, Neoplasms
- Being tested
- [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4Radiation
The dose of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 was calculated based on the patient's body weight to be 3.7 MBq [0.1 mCi]/kg, and the method of administration was intravenous push, with one single imaging administration.
| Study group | Role | What they receive |
|---|---|---|
| patients with solid tumors | Experimental | Subjects were recruited from Huashan Hospital of Fudan University. Receives: Radiation: [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors
The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.
Measured: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression
The secondary goal is to evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression.
Measured: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT
The third goal is to evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors.
Measured: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron-Emission TomographyStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203574
- Sponsor's protocol ID
- KY2023-1017
- Status last verified
- Jun 2024
- First submitted
- 3 Jan 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of TROP-2 PET/CT for Noninvasive Diagnosis of Solid Tumors
- ClinicalTrials.gov ID
- NCT06203574
- Acronym / sponsor ID
- KY2023-1017
- Conditions
- Positron-Emission Tomography, Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 12 Jan 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 will investigate the safety and preliminary diagnostic efficacy of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.
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 solid tumors | Experimental | Radiation: [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4Subjects were recruited from Huashan Hospital of Fudan University. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be between 18 and 65 years of age and of either sex.
- Patients with colorectal cancer confirmed by puncture or surgical pathology.
- Written informed consent signed by the subject or legal guardian or caregiver.
- Willingness and ability to cooperate with all programs of this study.
Key exclusion criteria (4 listed)
- Severe hepatic or renal insufficiency;
- Targeted therapy before radiotherapy or PET/CT scan；
- Renal function: serum creatinine less than or equal to the upper limit of the normal range;Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range；
- History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.
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 |
|---|---|---|
| [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4The dose of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 was calculated based on the patient's body weight to be 3.7 MBq [0.1 mCi]/kg, and the method of administration was intravenous push, with one single imaging administration. | Radiation | patients with solid tumors |
Primary outcome
evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors
Time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors.
evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression
Time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
The secondary goal is to evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression.
evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT
Time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
The third goal is to evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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. This study is not recruiting at the moment.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 in people with Positron-Emission Tomography and Neoplasms, run by Huashan 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 4 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: status not confirmed, as of the sponsor's last update on 18 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (13764308300 ext. +86, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors (time frame: 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4). 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 18 Jun 2024.