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Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.

NCT04276597 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-03-10

No results posted yet for this study

Summary

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.

The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Conditions

  • Pulmonary Neuroendocrine Neoplasm
  • Pheochromocytoma
  • Paraganglioma
  • Thymus Carcinoid
  • Unknown Primary Tumors
  • Neuroendocrine Tumors
  • Neuroendocrine Skin Carcinoma
  • Neuroendocrine Breast Tumor
  • Neuroendocrine Carcinoma Metastatic
  • Neuroendocrine Neoplasm of Ovary

Interventions

DRUG

177Lu-DOTATOC

177Lu labeled somatostatin receptors targeting ligand

Sponsors & Collaborators

  • Excel Diagnostics and Nuclear Oncology Center

    lead OTHER

Principal Investigators

  • Ebrahim Delpassand, MD · Excel Diagnostics and Nuclear Oncology Center

  • Rodolfo Nunez, MD · Excel Diagnostics and Nuclear Oncology Center

  • Afshin Shafie, MD · Excel Diagnostics and Nuclear Oncology Center

  • Ayman Gaber, MD · Excel Diagnostics and Nuclear Oncology Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2021-07-15
Completion
2021-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276597 on ClinicalTrials.gov