JPRN-jRCT2021220012
Recruiting
Phase 1
Evaluation of the pharmacokinetics, safety and efficacy of 211At-MABG in patients with pheochromocytoma/parganglioma
Shiga Tohru0 sites18 target enrollmentJune 17, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pheochromocytoma, paraganglioma
- Sponsor
- Shiga Tohru
- Enrollment
- 18
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All of the following conditions shall be met.
- •1\) Patients who can give their written consent by the individual
- •2\) Patients with histologically or clinically diagnosed pheochromocytoma, paraganglioma, malignant pheochromocytoma, or malignant paraganglioma
- •The diagnostic criteria will be in accordance with the 2018 Clinical Practice Guidelines for Pheochromocytoma and Paraganglioma.
- •3\) Patients diagnosed with pheochromocytoma are defined below (refractory pheochromocytoma is defined as those who satisfy any of the following (a) to (c) and are unable to undergo surgical resection or radical external irradiation)
- •(a) Pheochromocytoma/paraganglioma with a highly localized extension of the primary tumor at first presentation
- •(b) Malignant pheochromocytoma/malignant paraganglioma with distant metastasis at first presentation
- •(c) Pheochromocytoma/paraganglioma with local recurrence or distant metastasis despite surgical resection
- •4\) Patients aged 20 years or older
- •5\) Patients with an ECOG Performance status (PS) of 0\-2
Exclusion Criteria
- •Exclude patients who meet any of the following criteria:
- •1\) Patients with multiple active cancers
- •Active multiple cancers here are defined as synchronous double/multiple cancers and metachronous double/multiple cancers with a disease\-free interval of 5 years or less. However, lesions equivalent to carcinoma in situ or carcinoma in situ that are judged to be cured by local treatment and have a disease\-free period of more than 1 year after cure are not included in active multiple cancers. In addition, the following cancers associated with familial pheochromocytoma are not included in active double/multiple cancers.
- •(a) Medullary thyroid carcinoma in multiple endocrine neoplasia type 2 (MEN2\)
- •(b) Retinal hemangioblastoma in von Hippel Lindau disease (VHL)
- •(c) Neurofibromas in neurofibromatosis type 1 (NF1\)
- •2\) Patients who are unable to discontinue any drugs that suppress MABG accumulation for a predetermined period
- •3\) Patients who are unable to discontinue alpha\-methylparatyrosine for a predetermined period
- •4\) Patients who have undergone surgery, CVD therapy, catheter hepatic artery embolization for liver metastasis, or radiotherapy within 8 weeks prior to enrollment
- •5\) Patients who have received MIBG treatment within 12 weeks prior to enrollment
Outcomes
Primary Outcomes
Not specified
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