Pituitary TumoursPhase 3NCT02419664
Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
A Phase 3 study testing Gallium-68 DOTATOC PET in people with Pituitary Tumours, run by Göteborg University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Tumours
- What is being tested?
- Gallium-68 DOTATOC PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to 13 Jan 2022
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Naïve, unoperated pituitary tumour with GH or ACTH or TSH production or NFPA without treatment with somatostatin analogues or dopamine agonists.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center of Endocrinology and Metabolism, Sahlgrenska university Hospital
Gothenburg, SE-413 45
About this study
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
Read the detailed description
Background The most common cause to pituitary insufficiency is the pituitary adenoma (PA). PA may be divided into hormone producing PAs and non-functioning PAs (NFPA). Normal pituitary tissue, as well as tissues from PAs, expresses somatostatin receptors (sst). Five subtypes of sst receptors has been characterized.
Magnetic resonance tomography (MRI) presents anatomy, while in vivo diagnostics with somatostatin receptor scintigraphy (SRS) or position emission tomography (PET) reflect the functional properties of the tissue. The SRS have earlier been evaluated for diagnostics of pituitary diseases and has low discriminative ability to differ tumor tissue from normal pituitary tissue even though some secretory tumors and NFPA are seen. The superiority of the PET in diagnostics compared to the SRS is based on higher spatial resolution and a higher tumor to background ratio. Therefore it is of large interest to study Gallium 68 DOTATOC (Ga-PET) i small tumours that exhibit sst, such as in the pituitary, where high resolution is essential to discriminate from normal tissue and to evaluated residual tumor tissue postoperatively.
Aim with the project
To evaluate Ga-PET in the management of pituitary tumors and to seek the answer to the following questions:
- Is the method of value in primary diagnostics in PAs? Does Ga-PET contribute with more functional information than that given from an conventional MRI?
- Is the method of value in the follow-up, the detection of residual tumor tissue, and increase the possibility to differ scar tissue from true tumor?
- Can relapses of PA be detected earlier with Ga-PET than with conventional MRI?
- Are some of the sub-groups easier to detect that others??
- Can the pathological-anatomical findings and the immunochemical expression of sst be correlated to the PET findings?
- Can the treatment with somatostatin analogues be designed from the PET investigation and the sst analysis?
Method The aim is to recruit 10 patients with acromegaly (GH-producing PA), 10 patients with Cushing's disease (ACTH-producing PA), 5 patients with TSH-producing PA (TSHoma) and 20 patients with NFPA and to do Ga-PET before and after the pituitary surgery. In the Cushing patients, the TSHomas and in NFPA Ga-PET will also be dome after 3 years postoperatively to detect recurrences. At surgery, pituitary tissue is taken to investigate hormonal expression, sst and for further molecular genetic studies. At all PET occasions blood specimens from the patients are collected for future analyses. They will be kept in a freezer.
If difficulties to separate the Ga-Pet up-take in tumors from normal pituitary tissue the tumor expression may be enhanced by a somatostatin injection before Ga-PET that suppresses normal tissue.
The pituitary PET of pituitary tumours patients will be compared with the pituitary of patients with thyroid associated tumours performing PET according to the similar protocol in Another study
Significance This study is a pilot study. Ga-PET has not been used in pituitary tumors but there is known from studies in patients with gastrointestinal neuroendocrine tumors that the pituitary is seen on GA-PET. This is a "proof of concept". It addresses some of the clinical problems in the management of pituitary tumors. If the questions addressed in this study will be answered in advantage for PET, PET may be a routine investigation and the patients may avoid invasive procedures and repeated MRI. In addition, the patients may have better information regarding cure or not. If not, the treatment may be tailored from the sst receptor expression. This is of great importance for the patients and for the health care system.
- Conditions
- Pituitary Tumours
- Being tested
- Gallium-68 DOTATOC PET
- Keywords
- pituitary, pituitary adenomas, Ga-PET, Acromegaly, TSHomas, Cushing
- Medical subject headings
- Pituitary Neoplasms, Pituitary Diseases, Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium-68 DOTATOC PETDrug
Also called Ga-PET
The intervention is to administer Ga-68 DOTATOC in pituitary patients doing PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Ga-68 DOTATOC PET in pituitary adenomas | Experimental | 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. Receives: Drug: Gallium-68 DOTATOC PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary
Maximum Standardized Uptake Value
Measured: Baseline
SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary
Maximum Standardized Uptake Value
Measured: measured at 6 months +/- 2 weeks from baseline
SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary
Maximum Standardized Uptake Value
Measured: measured at 36 months +/- 2 weeks from baseline
Secondary outcomes (8)
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"
Measured: Baseline
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"
Measured: measured at 6 months +/- 2 weeks from baseline
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"
Measured: measured at 36 months +/- 2 weeks from baseline
Adverse event registration in association to Ga-68 PET
Measured: Baseline
Adverse event registration in association to Ga-68 PET
Measured: measured at 6 months +/- 2 weeks from baseline
Adverse event registration in association to Ga-68 PET
Measured: measured at 36 months +/- 2 weeks from baseline
Detection of tumour recurrence with Ga-PET
Measured: measured at 6 months +/- 2 weeks from baseline
Detection of tumour recurrence with Ga-PET
Measured: measured at 36 months +/- 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJan 2015
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Why it stopped: The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumoursStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Helena Filipsson Nyström, Ass Prof, Principal investigator, Center of Endocrinology and Metabolism, Dep of Endorinology, Sahlgrenska University Hospital, Göteborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419664
- Sponsor's protocol ID
- Ga-PET version 8 (141017)
- Other IDs
- 2010-020482-24
- Status last verified
- Mar 2022
- First submitted
- 19 Jan 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
- ClinicalTrials.gov ID
- NCT02419664
- Acronym / sponsor ID
- Ga-PET version 8 (141017)
- Conditions
- Pituitary Tumours
- Keywords
- pituitary, pituitary adenomas, Ga-PET, Acromegaly, TSHomas, Cushing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Uppsala University
- Study start
- Jan 2015 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 17 Apr 2015 (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.
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
Detailed description
Background The most common cause to pituitary insufficiency is the pituitary adenoma (PA). PA may be divided into hormone producing PAs and non-functioning PAs (NFPA). Normal pituitary tissue, as well as tissues from PAs, expresses somatostatin receptors (sst). Five subtypes of sst receptors has been characterized.
Magnetic resonance tomography (MRI) presents anatomy, while in vivo diagnostics with somatostatin receptor scintigraphy (SRS) or position emission tomography (PET) reflect the functional properties of the tissue. The SRS have earlier been evaluated for diagnostics of pituitary diseases and has low discriminative ability to differ tumor tissue from normal pituitary tissue even though some secretory tumors and NFPA are seen. The superiority of the PET in diagnostics compared to the SRS is based on higher spatial resolution and a higher tumor to background ratio. Therefore it is of large interest to study Gallium 68 DOTATOC (Ga-PET) i small tumours that exhibit sst, such as in the pituitary, where high resolution is essential to discriminate from normal tissue and to evaluated residual tumor tissue postoperatively.
Aim with the project
To evaluate Ga-PET in the management of pituitary tumors and to seek the answer to the following questions:
- Is the method of value in primary diagnostics in PAs? Does Ga-PET contribute with more functional information than that given from an conventional MRI?
- Is the method of value in the follow-up, the detection of residual tumor tissue, and increase the possibility to differ scar tissue from true tumor?
- Can relapses of PA be detected earlier with Ga-PET than with conventional MRI?
- Are some of the sub-groups easier to detect that others??
- Can the pathological-anatomical findings and the immunochemical expression of sst be correlated to the PET findings?
- Can the treatment with somatostatin analogues be designed from the PET investigation and the sst analysis?
Method The aim is to recruit 10 patients with acromegaly (GH-producing PA), 10 patients with Cushing's disease (ACTH-producing PA), 5 patients with TSH-producing PA (TSHoma) and 20 patients with NFPA and to do Ga-PET before and after the pituitary surgery. In the Cushing patients, the TSHomas and in NFPA Ga-PET will also be dome after 3 years postoperatively to detect recurrences. At surgery, pituitary tissue is taken to investigate hormonal expression, sst and for further molecular genetic studies. At all PET occasions blood specimens from the patients are collected for future analyses. They will be kept in a freezer.
If difficulties to separate the Ga-Pet up-take in tumors from normal pituitary tissue the tumor expression may be enhanced by a somatostatin injection before Ga-PET that suppresses normal tissue.
The pituitary PET of pituitary tumours patients will be compared with the pituitary of patients with thyroid associated tumours performing PET according to the similar protocol in Another study
Significance This study is a pilot study. Ga-PET has not been used in pituitary tumors but there is known from studies in patients with gastrointestinal neuroendocrine tumors that the pituitary is seen on GA-PET. This is a "proof of concept". It addresses some of the clinical problems in the management of pituitary tumors. If the questions addressed in this study will be answered in advantage for PET, PET may be a routine investigation and the patients may avoid invasive procedures and repeated MRI. In addition, the patients may have better information regarding cure or not. If not, the treatment may be tailored from the sst receptor expression. This is of great importance for the patients and for the health care system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga-68 DOTATOC PET in pituitary adenomas | Experimental | Drug: Gallium-68 DOTATOC PETTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Naïve, unoperated pituitary tumour with GH or ACTH or TSH production or NFPA without treatment with somatostatin analogues or dopamine agonists.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Gallium-68 DOTATOC PETAlso: Ga-PETThe intervention is to administer Ga-68 DOTATOC in pituitary patients doing PET/CT | Drug | Ga-68 DOTATOC PET in pituitary adenomas |
Primary outcome
SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary
Time frame: Baseline
Maximum Standardized Uptake Value
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
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
8 secondary outcomes
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
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
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
Adverse event registration in association to Ga-68 PET
Time frame: Baseline
Adverse event registration in association to Ga-68 PET
Time frame: measured at 6 months +/- 2 weeks from baseline
Adverse event registration in association to Ga-68 PET
Time frame: measured at 36 months +/- 2 weeks from baseline
Detection of tumour recurrence with Ga-PET
Time frame: measured at 6 months +/- 2 weeks from baseline
Detection of tumour recurrence with Ga-PET
Time frame: measured at 36 months +/- 2 weeks from baseline
Results and safety
The study was stopped early (reason given: The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Helena Filipsson Nyström, Ass Prof principal investigator
Center of Endocrinology and Metabolism, Dep of Endorinology, Sahlgrenska University Hospital, Göteborg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gallium-68 DOTATOC PET in people with Pituitary Tumours, run by Göteborg University at 1 site in Sweden.
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 6 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: stopped early, as of the sponsor's last update on 31 Mar 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 Sweden. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The hypothesis we had that we could predict the growth rate from PET uptake could not be confirmer and 3-year follow up was no longer considered motivated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV max in GA-68 DOTATOC in pituitary tumours in comparison to normal pituitary (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2022.