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Trial record 26 of 50 for:    DOTA- | Neuroendocrine Tumors

Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia

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ClinicalTrials.gov Identifier: NCT04045834
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoli Lan, Wuhan Union Hospital, China

Brief Summary:

Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO) , is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. NETs and mesenchymal tumors are often insidious and are undetectable by conventional imaging techniques including ultrasound, computed tomography and magnetic resonance, while a permanent cure will rely on exact localization and completely removal of the tumor.

Positron emission tomography (PET) provides a valuable tool for the diagnosis and differential diagnosis, staging, efficacy evaluation and recurrence monitoring of various tumors. NETs and mesenchymal tumors overexpress somatostatin receptors (SSTRs), so molecular imaging using radiolabeled somatostatin analogues may be one of the best ways to detect the occult tumors. Recently, somatostatin analogue labelled with gallium-68 (68Ga-DOTA-TATE) as a novel positron tracer has shown to be effective for the detection of NETs and mesenchymal tumors. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR,and PET / CT with specific imaging agent 68Ga-DOTA-TATE and conventional imaging agent [F-18]fluorodeoxyglucose to image patients suspected or confirmed NETs and TIO, the aim is to explore the value of hybrid PET/MR and PET/CT in neuroendocrine diseases and TIO.


Condition or disease Intervention/treatment
PET / CT PET / MR Neuroendocrine Tumors Osteomalacia Device: 68Ga-DOTA-TATE PET/MR and PET/CT imaging

Detailed Description:

Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO), is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. NETs and mesenchymal tumors are often insidious and are undetectable by conventional imaging techniques including ultrasound, computed tomography and magnetic resonance, while a permanent cure will rely on exact localization and completely removal of the tumor.

Positron emission tomography (PET) provides a valuable tool for the diagnosis and differential diagnosis, staging, efficacy evaluation and recurrence monitoring of various tumors. NETs and mesenchymal tumors overexpress somatostatin receptors (SSTRs), so molecular imaging using radiolabeled somatostatin analogues may be one of the best ways to detect the occult tumors. Recently, somatostatin analogue labelled with gallium-68 (68Ga-DOTA-TATE) as a novel positron tracer has shown to be effective for the detection of NETs and mesenchymal tumors. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR,and PET / CT with specific imaging agent 68Ga-DOTA-TATE and conventional imaging agent [F-18] fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with NETs and TIO, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging and determining treatment plan prior to treatment; for patients with a history of NETs and TIO, the aim is to evaluate the value of integrated PET/MR and PET/CT for treatment response assessment, detection of recurrences and metastatic lesions; for patients with inoperable and metastatic NETs, the aim is to find the value of integrated PET/MR and PET/CT in assessing the expression level of SSTRs to guide peptide receptor radionuclide therapy.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia
Actual Study Start Date : May 5, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021



Intervention Details:
  • Device: 68Ga-DOTA-TATE PET/MR and PET/CT imaging
    Intravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-TATE dose is about 2 MBq/kg body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi), 18F-FDG dose is about 3.7-5.4 MBq/kg (0.1 -0.15 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.


Primary Outcome Measures :
  1. Sensitivity and specificity of diagnosis and staging [ Time Frame: up to 2 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 SSTR 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. Special attention should be paid to the analysis of the causes of false positives and false negative results.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

About 90% of NETs, such as pancreatic endocrine tumors, pheochromocytoma, paraganglioma, gastrointestinal carcinoid, bronchial carcinoid, medullary thyroid carcinoma, small cell lung cancer, pituitary adenoma, some non-NETs (meninga) Tumor, astrocytoma, breast cancer, etc. have high expression of somatostatin receptor (SSTR).

TIO tumors are often derived from benign tumors of mesenchymal tissue, mostly located in bone or soft tissue, hiding in location, slow growth, and difficult to be found, making diagnosis difficult. According to reports in the literature, most of these tumors are positive for SSTR expression, and somatostatin receptor PET/CT imaging can locate lesions, which is a good method for screening TIO and has high specificity.

Criteria

Inclusion Criteria:

  • Patients with suspected or confirmed NETs or patients with suspected TIO

Exclusion Criteria:

  • Acute systemic diseases and electrolyte disorders.
  • Pregnant or lactating women.
  • Participated in other clinical trials within 4 weeks before the start of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045834


Contacts
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Contact: Lan Xiaoli, PhD +86-13886193262 lxl730724@hotmail.com

Locations
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China, Hubei
China, Hubei Province Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaoli Lan    +86-13886193262    lxl730724@hotmail.com   
Sponsors and Collaborators
Wuhan Union Hospital, China

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Responsible Party: Xiaoli Lan, Director of the Department of nuclear medicine, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT04045834     History of Changes
Other Study ID Numbers: XLan-S1002
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Osteomalacia
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders