177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT06395402
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lutetium Lu 177 dotatate therapy — DRUG
    LUTATHERA is an FDA approved radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumor (GEP-NET). This radiopharmaceutical binds to somatostatin receptors, which are overexpressed on GEP-NET cells, and subsequently delivers beta particle radiation to the tumor cells.

Study Details

The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will: * Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan * Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry) * Undergo blood tests for 4 to 8 weeks after each Lutathera treatment * Complete patient reported outcome questionnaires * Visit the clinic for follow-up about every 8 weeks.

Key Dates

Start date
May 3, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dosimetry-based lutetium Lu 177 dotatate therapy
    Intravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Intended administered radioactivity: Cycle 1: 200 millicuries (mCi) Cycles 2, 3, and 4: based upon dosimetry for radiation exposure to bone marrow (no more than 1 Gy per administration) and kidneys (maximum dose 28 Gy total). Not to exceed 400 millicuries (mCi) per cycle (1400 mCi maximum for all cycles).
  • Active Comparator: Standard lutetium Lu 177 dotatate
    Intravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Each cycle is intended to receive 200 millicuries of radioactivity for a total treatment of 800 millicuries.

Primary Outcome Measure

Objective Response Rate (ORR) at 6 months after treatment [ Time Frame: 6 months after completion of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Holden Comprehensive Cancer Center at the University of IowaIowa CityIowa52242
Kristin Gaimari-Varner, RN, BSN
[email protected]
319-384-9495
Kellie Bodeker, Ph.D.
[email protected]
319-384-9425
David Bushnell, MD (SUB_INVESTIGATOR)
Yusuf Menda, MD (SUB_INVESTIGATOR)
Janet Pollard, MD (SUB_INVESTIGATOR)
Parren McNeely, MD (SUB_INVESTIGATOR)
Michael Graham, MD, PhD (SUB_INVESTIGATOR)
Kristin Plichta, MD, PhD (SUB_INVESTIGATOR)
Stephen Graves, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
Holden Comprehensive Cancer Center at the University of Iowa· Iowa City, IA

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