Neuroendocrine TumorsNCT02743741
Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
A study testing Lutetium-177 Octreotate in people with Neuroendocrine Tumors, run by University Health Network, Toronto at 4 sites in Canada.
Trial summary
This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Lutetium-177 Octreotate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 4 sitesCanada
- Study dates
- 15 Jul 2016to 18 Aug 2026
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy-proven neuroendocrine tumor
- ECOG performance status ≤ 2
- Ki-67 index ≤ 30%
- Evidence of progressive disease demonstrated by imaging within six months prior to study enrollment as defined by RECIST v1.1.
- Tumor board discussion of cases to confirm suitability for participation in the clinical trial is required. Review should include but not limited to imaging review, pathology (including Ki 67) and treatment options.
- Patients with objective evidence (imaging, or biochemical) that is insufficient to be classified by RECIST 1.1 criteria can be eligible if after provincial multidisciplinary tumor board discussion a consensus for progression eligibility is reached.
Show all 23Show fewer
- The tumor board would consider exemptions if the magnitude of change is adequate by other definitions (e.g. using structural and contrast patterns and biochemical changes).
- Where clinically indicated, formal consultation on pathology, diagnostic imaging to facilitate criteria assessment (including 68Ga PET performed as part of the diagnostic procedure) is strongly recommended.
- Adequate lab parameters within 2 weeks prior to enrollment:
- Serum creatinine ≤ 150 μmol/L
- Calculated CrCl or measured GFR ≥ 30 mL/min (measured GFR may be done within 4 weeks prior to enrollment)
- Haemoglobin ≥ 90 g/L
- WBC ≥ 2 x 109/L
- Platelets ≥ 100 x 109/L
- Adequate liver function tests within 2 weeks prior to enrollment:
- total bilirubin ≤ 5 x ULN
- ALT ≤ 5 x ULN
- AST ≤ 5 x ULN
- alkaline phosphatase ≤ 5 x ULN
- Signed informed consent
- Patients with extensive bone metastases (e.g. >25% of bone marrow involvement are eligible but requires careful monitoring of hematological reserve
- Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Age ≥ 18 years.
Who cannot join
- Life expectancy <12 weeks
- An option for curative surgical or medical therapy or local liver embolization is feasible
- Candidate for curative and/or debulking surgical resections
- Systemic, biologic, other radioisotope, embolization therapies within ≤4 weeks prior to the first dose of 177Lu.
- Prior radiotherapy to target lesion(s) within ≤12 weeks prior to study enrollment [radiotherapy to non-target lesions permitted].
- Prior therapy with any systemic radionuclide therapy.
Show all 13Show fewer
- Radiotherapy to more than 25% of the bone marrow.
- Known brain metastases (unless metastases have been treated and are stable for ≥ 6 months).
- Uncontrolled diabetes mellitus
- Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).
- Second cancer(s) with clinical or biochemical progression within the last 3 years.
- Pregnancy or breast feeding. Female subjects must be surgically sterile or postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrolment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
- Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation, 68Ga or 177Lu administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Juravinski Cancer Centre
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario
Sunnybrook Odette Cancer Center
Toronto, Ontario
About this study
Official title: A Prospective Single-Arm, Multi-Centre, Study of the Efficacy and Safety of Lutetium-177 Octreotate (Lu-DOTATATE) Treatment With Individualized Dosimetry in Patients With 68Ga-DOTATATE Identified Somatostatin Receptor Positive Neuroendocrine Tumors
This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Lutetium-177 Octreotate
- Keywords
- Somatostatin Receptor Positive Neuroendocrine Tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium-177 OctreotateDrug
Also called Lu-DOTATATE, [Lu-177]-DOTATATE
Radiopharmaceutical
| Study group | Role | What they receive |
|---|---|---|
| Lutetium-177 Octreotate | Experimental | Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks Receives: Drug: Lutetium-177 Octreotate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients progression-free using RECIST 1.1 criteria
Measured: Up to 12 months
Secondary outcomes (5)
The overall response rate as determined by structural imaging using RECIST criteria.
Measured: Up to 5 years
The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA).
Measured: Up to 5 years
The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03
Measured: Up to 5 years
Overall survival
Measured: Up to 5 years
The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start15 Jul 2016
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ozmosis Research Inc., Cancer Care Ontario, Canadian Molecular Imaging Probe Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743741
- Sponsor's protocol ID
- OZM-067
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2016
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Macsuka MJ, Driscoll B, Yeung IWT, Publicover J, Metser U, Juergens R, Myrehaug SD, Laidley D, Wong RK, McGowan DR, Vallis KA. Cumulative Absorbed Dose and Successive Cyclic Reduction in Absorbed Dose Predict Response to 177Lu-DOTATATE in Neuroendocrine Tumors. J Nucl Med. 2026 May 1;67(5):751-757. doi: 10.2967/jnumed.125.271039.
PubMed 41611479