PET/CT imaging and dosimetry as predictive factors for treatment response of the 177Lu-DOTA-TATE therapy

• Conditions: C75.9; Endocrine gland, unspecified

• Registration Number: DRKS00004376
• Lead Sponsor: niversitätsklinikum Freiburg, Abteilung Nuklearmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-20
• Study Completion: 2023-01-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

indication for 177Lu-DOTATATE therapy:
- well differenciated, metastasized neuroendocrine tumors or carcinoma, which overexpress somatostatin receptors subtyp 2 (positive pretherapeutic 68Ga-DOTA-TATE PET/CT) and which are not able to treat curative,
- meningiomas, which overexpress somatostatin receptors subtyp 2 and which are not able to treat with an alternative treatment.

pro DOTATATE therapy:
- progress of tumor, firt line, second line therapy,
- metastasis, not local restricted to the liver,
- significant overexpression of somatostatin receptor subtyp 2,
- normal kidney function.

- able and willing to give informed consent

Exclusion Criteria

- renal insufficiency, creatinine >1.5 mg/dl and/or GFR <60 ml/min, fixed disease of the efferent urinary tract
- myelosupression: thrombocytes <90tds/mycroliter, hemoglobin <8.0 g/dl, leucocytes <2.5 tds/mycroliter
- Karnofsky index <60%
- somatostatin receptor imaging: tumor-uptake < liver-uptake
- pregnancy

- relative contra-indication: proliferation index >20%

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
triple phase CT scan; decrease in lesion-volume [ml]

Secondary Outcome Measures

Name	Time	Method
SUVmax [g/ml], tumor doses [Gy/GBq], kidney doses [Gy/GBq], correlation between conventional dosimetry and voxel-based dosimetry