Neuroendocrine TumorsPhase 1NCT03478358
Treatment Using 177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
A Phase 1 study testing 177Lu-DOTA-EB-TATE 1, 177Lu-DOTA-TATE and 177Lu-DOTA-EB-TATE 2 in people with Neuroendocrine Tumors, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-DOTA-EB-TATE 1, 177Lu-DOTA-TATE and 177Lu-DOTA-EB-TATE 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2017to 1 May 2023
- Phase
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptorexpressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.
Who cannot join
- The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Hao Wang, PhD., +86 10 69154196
About this study
Official title: Treatment of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors
This is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE, 3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. Besides, we evaluated the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.
Read the detailed description
Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guidelines for unresectable and metastatic NET recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. Radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic NETs and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-Dotatate has been its short half-life and fast rate of clearance. Kidney is considered one of the dose-limiting organs in peptide receptor radionuclide therapy (PRRT). Amino acid has been infused to reduce renal absorbed dose by inhibiting the proximal tubular reabsorption of the radiopeptide. This study was designed to compare the efficacy of a long-lasting radiolabeled somatostatin analogue 177Lu-DOTA-EB-TATE with 177Lu-DOTA-TATE in patients with advanced metastatic neuroendocrine tumors and evaluate the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 177Lu-DOTA-EB-TATE 1, 177Lu-DOTA-TATE, 177Lu-DOTA-EB-TATE 2, 177Lu-DOTA-EB-TATE 3, 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine)
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTA-EB-TATE 1Drug
The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
177Lu-DOTA-TATEDrug
The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
177Lu-DOTA-EB-TATE 2Drug
The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
177Lu-DOTA-EB-TATE 3Drug
The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine)Drug
The patients were intravenously injected with 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and amino acids (lysine and arginine).
3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine)Drug
The patients were intravenously injected with 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine).
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-DOTA-EB-TATE 1 | Experimental | The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. Receives: Drug: 177Lu-DOTA-EB-TATE 1 |
| 177Lu-DOTA-EB-TATE 2 | Experimental | The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. Receives: Drug: 177Lu-DOTA-EB-TATE 2 |
| 177Lu-DOTA-EB-TATE 3 | Experimental | The patients were intravenously injected with single dose 3.7 GBq (100 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. Receives: Drug: 177Lu-DOTA-EB-TATE 3 |
| 177Lu-DOTA-TATE | Experimental | The patients were intravenously injected with single dose 3.7 GBq (100 mCi) of 177LuDOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. Receives: Drug: 177Lu-DOTA-TATE |
| 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine) | Experimental | The patients were intravenously injected with 3.7 GBq (100 mCi) of 177LuDOTA-TATE and amino acids (lysine and arginine). Receives: Drug: 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine) |
| 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine) | Experimental | The patients were intravenously injected with 3.7 GBq (100 mCi) of 177LuDOTA-TATE without amino acids (lysine and arginine). Receives: Drug: 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value before and after the treatment in metastatic neuroendocrine tumors will be measured.
Measured: 1 year
the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
Hematological parameters, liver, and renal function at baseline, 1 week and 4 weeks after PRRT were tested. 99mTc-DTPA dynamic renal imaging for the determination of the glomerular filtration rate (GFR) was performed at baseline and 8 weeks after each cycle of PRRT.
Measured: 1 year
Secondary outcomes (1)
the dosimetry of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
the absorbed dose for kidney and whole-body evaluated through HERMES software.
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 posted27 Mar 2018
- Study start30 Apr 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, M.D.,PhD, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478358
- Sponsor's protocol ID
- PekingUMCH-NM018
- Status last verified
- Aug 2022
- First submitted
- 5 Feb 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang Y, Liu Q, Wang G, Zhang J, Zhu Z, Chen X. Evaluation of Safety, Biodistribution, and Dosimetry of a Long-Acting Radiolabeled Somatostatin Analog 177 Lu-DOTA-EB-TATE With and Without Amino Acid Infusion. Clin Nucl Med. 2023 Jun 1;48(6):e289-e293. doi: 10.1097/RLU.0000000000004642. Epub 2023 Apr 18.
PubMed 37075254Liu Q, Cheng Y, Zang J, Sui H, Wang H, Jacobson O, Zhu Z, Chen X. Dose escalation of an Evans blue-modified radiolabeled somatostatin analog 177Lu-DOTA-EB-TATE in the treatment of metastatic neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2020 Apr;47(4):947-957. doi: 10.1007/s00259-019-04530-1. Epub 2019 Dec 12.
PubMed 31832728
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT03478358
- Acronym / sponsor ID
- PekingUMCH-NM018
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 27 Mar 2018 (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 is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE, 3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. Besides, we evaluated the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.
Detailed description
Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guidelines for unresectable and metastatic NET recommend somatostatin analogues as first-line treatment, but do not recommend a particular treatment sequence for the remaining therapies. Radiolabeled somatostatin analogue therapy, also known as peptide receptor radionuclide therapy has become a well-accepted treatment for patients with well to moderately differentiated unresectable or metastatic NETs and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-Dotatate has been its short half-life and fast rate of clearance. Kidney is considered one of the dose-limiting organs in peptide receptor radionuclide therapy (PRRT). Amino acid has been infused to reduce renal absorbed dose by inhibiting the proximal tubular reabsorption of the radiopeptide. This study was designed to compare the efficacy of a long-lasting radiolabeled somatostatin analogue 177Lu-DOTA-EB-TATE with 177Lu-DOTA-TATE in patients with advanced metastatic neuroendocrine tumors and evaluate the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 177Lu-DOTA-EB-TATE 1 | Experimental | Drug: 177Lu-DOTA-EB-TATE 1The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. |
| 177Lu-DOTA-EB-TATE 2 | Experimental | Drug: 177Lu-DOTA-EB-TATE 2The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. |
| 177Lu-DOTA-EB-TATE 3 | Experimental | Drug: 177Lu-DOTA-EB-TATE 3The patients were intravenously injected with single dose 3.7 GBq (100 mCi) of 177LuDOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. |
| 177Lu-DOTA-TATE | Experimental | Drug: 177Lu-DOTA-TATEThe patients were intravenously injected with single dose 3.7 GBq (100 mCi) of 177LuDOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. |
| 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine) | Experimental | Drug: 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine)The patients were intravenously injected with 3.7 GBq (100 mCi) of 177LuDOTA-TATE and amino acids (lysine and arginine). |
| 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine) | Experimental | Drug: 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine)The patients were intravenously injected with 3.7 GBq (100 mCi) of 177LuDOTA-TATE without amino acids (lysine and arginine). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptorexpressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.
Key exclusion criteria (1 listed)
- The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.
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 |
|---|---|---|
| 177Lu-DOTA-EB-TATE 1The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. | Drug | 177Lu-DOTA-EB-TATE 1 |
| 177Lu-DOTA-TATEThe patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. | Drug | 177Lu-DOTA-TATE |
| 177Lu-DOTA-EB-TATE 2The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. | Drug | 177Lu-DOTA-EB-TATE 2 |
| 177Lu-DOTA-EB-TATE 3The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment. | Drug | 177Lu-DOTA-EB-TATE 3 |
| 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine)The patients were intravenously injected with 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and amino acids (lysine and arginine). | Drug | 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE with amino acids (lysine and arginine) |
| 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine)The patients were intravenously injected with 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine). | Drug | 3.7 GBq (100 mCi) of 177Lu-DOTA-EB-TATE without amino acids (lysine and arginine) |
Primary outcome
Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors
Time frame: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value before and after the treatment in metastatic neuroendocrine tumors will be measured.
the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
Time frame: 1 year
Hematological parameters, liver, and renal function at baseline, 1 week and 4 weeks after PRRT were tested. 99mTc-DTPA dynamic renal imaging for the determination of the glomerular filtration rate (GFR) was performed at baseline and 8 weeks after each cycle of PRRT.
1 secondary outcome
the dosimetry of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 37075254Jiang Y, Liu Q, Wang G, Zhang J, Zhu Z, Chen X. Evaluation of Safety, Biodistribution, and Dosimetry of a Long-Acting Radiolabeled Somatostatin Analog 177 Lu-DOTA-EB-TATE With and Without Amino Acid Infusion. Clin Nucl Med. 2023 Jun 1;48(6):e289-e293. doi: 10.1097/RLU.0000000000004642. Epub 2023 Apr 18.
- Derived from this study: PubMed 31832728Liu Q, Cheng Y, Zang J, Sui H, Wang H, Jacobson O, Zhu Z, Chen X. Dose escalation of an Evans blue-modified radiolabeled somatostatin analog 177Lu-DOTA-EB-TATE in the treatment of metastatic neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2020 Apr;47(4):947-957. doi: 10.1007/s00259-019-04530-1. Epub 2019 Dec 12.
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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.
Zhaohui Zhu, M.D.,PhD study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 177Lu-DOTA-EB-TATE 1, 177Lu-DOTA-TATE and 177Lu-DOTA-EB-TATE 2 in people with Neuroendocrine Tumors, 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 1 inclusion and 1 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 31 Aug 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hao Wang, PhD (+86 10 69154196, 474556259@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03478358, which also lists 2 linked publications.
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 31 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.