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Ga-68-DOTATOC -PET in the Management of Pituitary Tumours

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ClinicalTrials.gov Identifier: NCT02419664
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Uppsala University
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists.

Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products.

Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later


Condition or disease Intervention/treatment Phase
Pituitary Tumours Procedure: Gallium-68 DOTATOC PET Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
Actual Study Start Date : January 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Ga-68 DOTATOC PET in pituitary adenomas

To give Ga-68 DOTATOC in pituitary patients doing PET/CT

They are compared with Ga-68 DOTATOC PET performed in another study on patients with no pituitary disease.

Procedure: Gallium-68 DOTATOC PET
The intervention is to administer Ga-68 DOTATOC in pituitary patients doing PET/CT
Other Name: Ga-PET




Primary Outcome Measures :
  1. SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary [ Time Frame: Baseline ]
    Maximum Standardized Uptake Value

  2. SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary [ Time Frame: measured at 6 months +/- 2 weeks from baseline ]
    Maximum Standardized Uptake Value

  3. SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary [ Time Frame: measured at 36 months +/- 2 weeks from baseline ]
    Maximum Standardized Uptake Value


Secondary Outcome Measures :
  1. Ga-PET uptake in correlation to sst expression in pituitary tumours, measured as SUVmax which is then used to establish statistical relationship with a cell membrane-based sst-immunohistochemistry (IHC) score" [ Time Frame: Baseline ]
  2. Ga-PET uptake in correlation to sst expression in pituitary tumours, measured as SUVmax which is then used to establish statistical relationship with a cell membrane-based sst-immunohistochemistry (IHC) score" [ Time Frame: measured at 6 months +/- 2 weeks from baseline ]
  3. Ga-PET uptake in correlation to sst expression in pituitary tumours, measured as SUVmax which is then used to establish statistical relationship with a cell membrane-based sst-immunohistochemistry (IHC) score" [ Time Frame: measured at 36 months +/- 2 weeks from baseline ]
  4. Adverse event registration in association to Ga-68 PET [ Time Frame: Baseline ]
  5. Adverse event registration in association to Ga-68 PET [ Time Frame: measured at 6 months +/- 2 weeks from baseline ]
  6. Adverse event registration in association to Ga-68 PET [ Time Frame: measured at 36 months +/- 2 weeks from baseline ]
  7. Detection of tumour recurrence with Ga-PET [ Time Frame: measured at 6 months +/- 2 weeks from baseline ]
  8. Detection of tumour recurrence with Ga-PET [ Time Frame: measured at 36 months +/- 2 weeks from baseline ]

Other Outcome Measures:
  1. Dynamic measurements of Ga-68 Dotatoc in the pituitary [include the dynamic measure of SUVmax, blood flow, [ Time Frame: Baseline ]
  2. Dynamic measurements of Ga-68 Dotatoc in the pituitary [include the dynamic measure of SUVmax, blood flow, [ Time Frame: measured at 6 months +/- 2 weeks from baseline ]
  3. Dynamic measurements of Ga-68 Dotatoc in the pituitary [include the dynamic measure of SUVmax, blood flow, [ Time Frame: measured at 36 months +/- 2 weeks from baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Naïve, unoperated pituitary tumour with GH or ACTH or TSH production or NFPA without treatment with somatostatin analogues or dopamine agonists.

Exclusion Criteria:

  • Patient who may not attend to the protocol according to the investigators opinion.
  • Pregnancy or lactating
  • Isolated prolactin producing tumours
  • Overproduction of gonadotrophins
  • Carcinoids ie ectopic CRF production
  • Known or suspected allergy to the trial product or related products.

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): NCT02419664


Contacts
Contact: Axel Tjörnstrand, PhD student +46705833398 axel.tjornstrand@vgregion.se
Contact: Helena Filipsson Nyström, Ass Prof +46705833398 helena.filipsson@telia.com

Locations
Sweden
Center of Endocrinology and Metabolism, Sahlgrenska university Hospital Recruiting
Göteborg, Sweden, SE-413 45
Contact: Lena Kullin, Nurse    +46313421000    lena.kullin@vgregion.se   
Contact: Helena Filipsson Nyström, Ass Prof    +46705833398    helena.filipsson@telia.com   
Sub-Investigator: Peter Gjertson, ass prof         
Sub-Investigator: Oleksiy Itsenko, Radiochemist         
Sub-Investigator: Jakob Himmelmann, Radiophysics         
Sub-Investigator: Anders Sundin, Prof         
Sub-Investigator: Michael Schöll, Post doc         
Sub-Investigator: Axel Tjörnstrand, PhD student         
Principal Investigator: Helena Filipsson Nyström, Ass Prf         
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Uppsala University
Investigators
Principal Investigator: Helena Filipsson Nyström, Ass Prof Center of Endocrinology and Metabolism, Dep of Endorinology, Sahlgrenska University Hospital, Göteborg, Sweden

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02419664     History of Changes
Other Study ID Numbers: Ga-PET version 8 (141017)
2010-020482-24 ( EudraCT Number )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Keywords provided by Göteborg University:
pituitary
pituitary adenomas
Ga-PET
Acromegaly
TSHomas
Cushing

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Edotreotide
Octreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents