A prospective study of the use of 68Ga-DOTA-TATE PET/CT in patients with neuroendocrine tumors.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004313-13-SE

Enrollment

450

Registered

2012-10-24

Start date

2013-01-22

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with neuroendocrine tumors, who are going to be diagnosed/evaluated with 68Ga-DOTA-TATE PET/CT instead of standard Octreoscan MedDRA version: 14.1 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864

Interventions

Product Name: 68Ga-DOTA-TATE Pharmaceutical Form: Radiopharmaceutical precursor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 years or more Signed written informed concent Follow up of previous diagnosed neuroendocrine tumor or is under investigation for suspect neuroendocrine tumor Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 315

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Age less than 18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To collect data from patients with neuroendocrine tumors, diagnosed and followed up by the radioactive isotope 68Ga-DOTA-TATE, and to correlate these data with other imaging techniques and data from the patients medical records.;Secondary Objective: To describe how the use of long acting somastotatine analogue influences the result of 68Ga-DOTA-TATE PET/CT Amont the population with metastatic neuroendocrine tumor, and are planned for treatment with 177Lu-DOTA-TATE create a model for objective quantification of the uptake of 68Ga-DOTA-TATE in tumor versus normal tissue and compare with the usual "Krenning-index, now beeing used as a predictive factor selection of patients for peptide receptor radionuclide therapy based on octreotid scintigraphy.;Primary end point(s): To describe the result of 68Ga-DOTA-TATE PET/CT regarding metastases and intensity of uptake and to correlate this with other imaging techniques and data from the patients medical records with respect to disease progression.;Timepoint(s) of evaluation of this end point: At diagnosis, and follow up.	—

Measure

Time frame

Main Objective: To collect data from patients with neuroendocrine tumors, diagnosed and followed up by the radioactive isotope 68Ga-DOTA-TATE, and to correlate these data with other imaging techniques and data from the patients medical records.;Secondary Objective: To describe how the use of long acting somastotatine analogue influences the result of 68Ga-DOTA-TATE PET/CT Amont the population with metastatic neuroendocrine tumor, and are planned for treatment with 177Lu-DOTA-TATE create a model for objective quantification of the uptake of 68Ga-DOTA-TATE in tumor versus normal tissue and compare with the usual "Krenning-index, now beeing used as a predictive factor selection of patients for peptide receptor radionuclide therapy based on octreotid scintigraphy.;Primary end point(s): To describe the result of 68Ga-DOTA-TATE PET/CT regarding metastases and intensity of uptake and to correlate this with other imaging techniques and data from the patients medical records with respect to disease progression.;Timepoint(s) of evaluation of this end point: At diagnosis, and follow up.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Sweden

Contacts

Public ContactJan Tennvall

Skåne University Hospital, Dept of Oncology

jan.tennvall@med.lu.se+464617 75 20

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026