Lung CancerEarly Phase 1NCT02817945
Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging
A Early Phase 1 study testing 68Ga-NOTA-3P-TATE-RGD in people with Lung Cancer and Neuroendocrine Neoplasm, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Neuroendocrine Neoplasm
- What is being tested?
- 68Ga-NOTA-3P-TATE-RGD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 31 Dec 2022
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
- To provide basic information and sign the written informed consent.
Who cannot join
- Consisted of conditions of mental illness;
- Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
- Severe allergy or hypersensitivity to IV radiographic contrast
- Claustrophobia to accept the PET/CT scanning
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, MD, +8613611093752, 13611093752@163.com
About this study
Official title: 68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Read the detailed description
The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.
- Conditions
- Lung Cancer, Neuroendocrine Neoplasm
- Being tested
- 68Ga-NOTA-3P-TATE-RGD
- Keywords
- TATE-RGD, SSTR2, integrin αvβ3
- Medical subject headings
- Lung Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-3P-TATE-RGDDrug
68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-3P-TATE-RGD PET/CT | Experimental | The patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later. Receives: Drug: 68Ga-NOTA-3P-TATE-RGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast cancer will be measured.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Dec 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817945
- Sponsor's protocol ID
- PUMCHNM13
- Status last verified
- Mar 2022
- First submitted
- 27 Jun 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang Y, Liu Q, Wang G, Sui H, Wang R, Wang J, Zhu Z. A prospective head-to-head comparison of 68 Ga-NOTA-3P-TATE-RGD and 68 Ga-DOTATATE in patients with gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4218-4227. doi: 10.1007/s00259-022-05852-3. Epub 2022 Jun 3.
PubMed 35657429
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams
- ClinicalTrials.gov ID
- NCT02817945
- Acronym / sponsor ID
- PUMCHNM13
- Conditions
- Lung Cancer, Neuroendocrine Neoplasm
- Keywords
- TATE-RGD, SSTR2, integrin αvβ3
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- 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 is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed description
The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-3P-TATE-RGD PET/CT | Experimental | Drug: 68Ga-NOTA-3P-TATE-RGDThe patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
- To provide basic information and sign the written informed consent.
Key exclusion criteria (5 listed)
- Consisted of conditions of mental illness;
- Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
- Severe allergy or hypersensitivity to IV radiographic contrast
- Claustrophobia to accept the PET/CT scanning
- Pregnancy or breast feeding
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-NOTA-3P-TATE-RGD68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans | Drug | 68Ga-NOTA-3P-TATE-RGD PET/CT |
Primary outcome
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
Time frame: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast cancer will be measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 35657429Jiang Y, Liu Q, Wang G, Sui H, Wang R, Wang J, Zhu Z. A prospective head-to-head comparison of 68 Ga-NOTA-3P-TATE-RGD and 68 Ga-DOTATATE in patients with gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4218-4227. doi: 10.1007/s00259-022-05852-3. Epub 2022 Jun 3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-NOTA-3P-TATE-RGD in people with Lung Cancer and Neuroendocrine Neoplasm, run by Peking Union Medical College 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 2 inclusion and 5 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 7 Apr 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhaohui Zhu, MD (+8613611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02817945, which also lists 1 linked publication.
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 7 Apr 2022.