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Neuroendocrine TumorsEarly Phase 1NCT04041882

68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

A Early Phase 1 study testing 68Ga-DOTATATE in people with Neuroendocrine Tumors, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. Read more about this study

Who is it for?
Ages 7 to 80 years
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
68Ga-DOTATATE
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 Apr 2014to 30 Jan 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 7 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.

Who cannot join

  • pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

Trial locations and contacts

1 site in 1 country.

Zhaohui Zhu, MD,PhD contact

+86-10-69154196

zhuzhh@pumch.cn

China1 site, 1 recruiting

  • Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science

    Beijing

    Zhaohui Zhu, MD,PhD, 86-10-69154196, zhuzhh@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: 68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor

Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. This prospective study is going to investigate whether radiolabeled somatostatin analogs 68Ga-DOTATATE PET/CT may be valuable for diagnosis, risk stratification, and prognostic evaluation of neuroendocrine tumors and compared it with 18F-FDG PET/CT.

Read the detailed description

Neuroendocrine tumor(NET)can be derived from endocrine glands, endocrine tissues and endocrine cells from any parts of body. Due to its occult onset and heterogeneity, it is hard to be detected by conventional imaging like CT and it is often at late stage when diagnosed. New imaging modality such as 18F-FDG PET/CT have been well-accepted as a practical way to evaluate the aggressive of tumor. 18F-FDG PET/CT has been used to improve the efficacy in assessing the extent and severity of NET, but the diagnostic accuracy of 18F-FDG PET/CT decreased in low proliferation tumor cells and inflammation. Recent studies showed somatostatin receptor (SSTR) was expressed in NET cells and SSTR-targeting molecular imaging-68Ga-DOTATATE PET/CT could be a promising technique to evaluate the extent of NET with higher accuracy. Especially in some well differentiated tumor, 18F-FDG PET/CT can be negative, while 68Ga-DOTATATE PET/CT can be positive. However, the results can be varied in these two imaging modalities and characterized this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome.This prospective study is going to investigate whether 68Ga-DOTATATE PET/CT may be superior to 18F-FDG PET/CT for diagnosis, risk stratification, and prognostic evaluation of NET.

Being tested
68Ga-DOTATATE
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-DOTATATEDrug

    Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-DOTATATE. Tracer doses of 68Ga-DOTATATE will be used to image lesions of NET PET/CT scan.

Study groups in NCT04041882
Study groupRoleWhat they receive
68Ga-DOTATATE PET/CTExperimentalInject 68Ga-DOTATATE and then perform PET/CT scan
Receives: Drug: 68Ga-DOTATATE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SUVmax

    SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive.

    Measured: through study completion, an average of 3 years

  2. Diagnostic value

    Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT

    Measured: through study completion, an average of 3 years

Secondary outcomes (5)

  1. Diagnostic value in different grades/types of NET

    Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on.

    Measured: through study completion, an average of 3 years

  2. Overall Survival(OS)

    Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT

    Measured: 1 year and 5 years after been diagnosed

  3. Progressive free survival(PFS)

    Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT

    Measured: 1 year and 5 years after been diagnosed

  4. SSTR expression/Ki67 and SUV

    Correlation between SSTR expression/Ki 67 and SUV in PET

    Measured: through study completion, an average of 3 years

  5. Risk stratification

    Analysis of risk factors and OS/PFS

    Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start1 Apr 2014
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Jan 2022 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04041882
Sponsor's protocol ID
PekingUMCH-NM022
Status last verified
Jul 2019
First submitted
30 Jul 2019
Last updated
1 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Q, Zang J, Yang Y, Ling Q, Wu H, Wang P, Lu L, Zhu Z. Head-to-head comparison of 68Ga-DOTATATE PET/CT and 18F-FDG PET/CT in localizing tumors with ectopic adrenocorticotropic hormone secretion: a prospective study. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4386-4395. doi: 10.1007/s00259-021-05370-8. Epub 2021 Jun 19.

    PubMed 34146130

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 68Ga-DOTATATE 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 1 Aug 2019. 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,PhD (+86-10-69154196, zhuzhh@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SUVmax (time frame: through study completion, an average of 3 years). 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 NCT04041882, 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 1 Aug 2019.

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