Pancreatic Ductal AdenocarcinomaNCT05048810
Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma
A study testing 68Ga-DOTA-NT-20.3 in people with Pancreatic Ductal Adenocarcinoma, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- 68Ga-DOTA-NT-20.3
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2020to 1 Mar 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with pathohistologically proven localized or metastatic PDAC;
- patient aged 18 or older, male or female, who can provide written informed consent for this study;
- patient with complete clinical data.
Who cannot join
- patient age < 18 years;
- patient with other active cancer;
- patient with PDAC under the treatment blocking NT receptors;
- pregnant or lactating women;
- patient who cannot stay on PET/CT camera for app. 90 minutes;
- patient who cannot stand MRI;
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- patient simultaneously participating in another clinical trial;
- patient with HIV, HCV, HVB infection or other serious chronic infection
- patient with serious mental, neurological, cardiovascular, respiratory and other system diseases;
- patient with liver and kidney function (GFR less than 50 ml/min) disease;
- patient with severe severe refractory mental disorder.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with pancreatic ductal adenocarcinoma (PDAC).
Read the detailed description
This study is design to prospectively investigate the safety and efficacy of 68Ga-DOTA-NT-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with PDAC. Neurotensin receptor 1 (NTR-1) is the high affinity receptor of Neurotensin (NT), which was found abnormal expression in the early stages of PDAC malignant cell transformation. 68Ga-DOTA-NT-20.3 as a new NTR-1 targeted probe was prepared and showed good uptake on PDAC cell line and animal studies. The study intends to recruit 6 PDAC volunteers to participate in the experiment. Patients were evaluated with 18F-fluorodeoxyglucose (18F-FDG). And then all patients underwent a single-injection with 68Ga-DOTA-NT-20.3, dual-modality imaging protocol consisting of a PET/CT and subsequent PET/MR scan. The follow-up period was followed up to assess safety and effectiveness.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- 68Ga-DOTA-NT-20.3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-NT-20.3Radiation
In this study, all patients will receive one injection of 68Ga-DOTA-NT-20.3, a PET radiopharmaceutical selective for neurotensin receptor 1 (NTR-1). For the injection, subjects will receive a target dose of 2-4 MBq per kg of body weight as a bolus injection. 68Ga-DOTA-NT-20.3 injection will be followed by a 10 ml saline flush.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-NT-20.3 | Experimental | Subjects will undergo PET imaging using 68Ga-DOTA-NT-20.3. Receives: Radiation: 68Ga-DOTA-NT-20.3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of diagnosis and staging
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The signal intensity of PET indicates the presence and density of NTR-1 in the tissue. The lesion intake is higher than the liver and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, and calculate the T/B ratio.
Measured: 3 years
Secondary outcomes (2)
NTR-1 receptor expression by histology compared to tracer uptake
Pathological detection of NTR-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT/MR.
Measured: 3 years
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Safety and tolerability profile for the administration of 68Ga-DOTA-NT-20.3 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Feb 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FengWang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Feng Wang, Ph.D, Study director, Nuclear Medicine Department, Nanjing First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048810
- Sponsor's protocol ID
- 68Ga-DOTA-NT-20.3
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2020
- Last updated
- 14 Sep 2023
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05048810
- Acronym / sponsor ID
- 68Ga-DOTA-NT-20.3
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 17 Sep 2021 (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 purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with pancreatic ductal adenocarcinoma (PDAC).
Detailed description
This study is design to prospectively investigate the safety and efficacy of 68Ga-DOTA-NT-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with PDAC. Neurotensin receptor 1 (NTR-1) is the high affinity receptor of Neurotensin (NT), which was found abnormal expression in the early stages of PDAC malignant cell transformation. 68Ga-DOTA-NT-20.3 as a new NTR-1 targeted probe was prepared and showed good uptake on PDAC cell line and animal studies. The study intends to recruit 6 PDAC volunteers to participate in the experiment. Patients were evaluated with 18F-fluorodeoxyglucose (18F-FDG). And then all patients underwent a single-injection with 68Ga-DOTA-NT-20.3, dual-modality imaging protocol consisting of a PET/CT and subsequent PET/MR scan. The follow-up period was followed up to assess safety and effectiveness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-NT-20.3 | Experimental | Radiation: 68Ga-DOTA-NT-20.3Subjects will undergo PET imaging using 68Ga-DOTA-NT-20.3. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient with pathohistologically proven localized or metastatic PDAC;
- patient aged 18 or older, male or female, who can provide written informed consent for this study;
- patient with complete clinical data.
Key exclusion criteria (11 listed)
- patient age < 18 years;
- patient with other active cancer;
- patient with PDAC under the treatment blocking NT receptors;
- pregnant or lactating women;
- patient who cannot stay on PET/CT camera for app. 90 minutes;
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-DOTA-NT-20.3In this study, all patients will receive one injection of 68Ga-DOTA-NT-20.3, a PET radiopharmaceutical selective for neurotensin receptor 1 (NTR-1). For the injection, subjects will receive a target dose of 2-4 MBq per kg of body weight as a bolus injection. 68Ga-DOTA-NT-20.3 injection will be followed by a 10 ml saline flush. | Radiation | 68Ga-DOTA-NT-20.3 |
Primary outcome
Sensitivity and specificity of diagnosis and staging
Time frame: 3 years
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The signal intensity of PET indicates the presence and density of NTR-1 in the tissue. The lesion intake is higher than the liver and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, and calculate the T/B ratio.
2 secondary outcomes
NTR-1 receptor expression by histology compared to tracer uptake
Time frame: 3 years
Safety and Tolerability Profile Measured by Adverse Events (AEs)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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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.
Feng Wang, Ph.D study director
Nuclear Medicine Department, Nanjing First 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-DOTA-NT-20.3 in people with Pancreatic Ductal Adenocarcinoma, run by Nanjing First Hospital, Nanjing Medical University 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 14 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of diagnosis and staging (time frame: 3 years). 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 14 Sep 2023.