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New treatment option for Neuroendocrine Tumors
Official title 177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
ClinicalTrials.gov ID: NCT06395402
What this study is testing
What is Lutetium Lu 177 dotatate therapy?
Lutetium Lu 177 dotatate therapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for neuroendocrine tumors.
Also referred to as Lutathera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria. A physical, with vital signs...
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged ≥ 18 years at time of consent.
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%)...
You likely can't join if
- Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \& dump' strategy; lactation must be discontinued).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of...
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new...
- Prior peptide-receptor radiotherapy (PRRT).
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).
- A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound/negatively impact study...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria. A physical, with vital signs, concomitant medication review, and medical history must be completed within 60...
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged ≥ 18 years at time of consent.
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be...
- Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake \> liver background on sstr2 PET/CT with any FDA approved sstr2 imaging agent. SSTR2 PET/CT must have been obtained within 90...
- Recommended to receive LUTATHERA® therapy for unresectable and/or metastatic neuroendocrine disease.
- Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of ≥70).
- Agrees to contraception during therapy.
- Neutrophil count within normal limits within 28 days of treatment day 1.
- Platelet count within normal limits within 28 days of treatment day 1.
- Ability to take oral medication and be willing to adhere to the treatment regimen
- For individuals of reproductive potential: agreement to use effective birth control
- Agreement to adhere to Lifestyle Considerations throughout study duration: abstain from caffeine or xanthine-containing products as well as alcohol before the start of cycle dosing and through the cycle's final blood...
- Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \& dump' strategy; lactation must be discontinued).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina...
- Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
- Prior peptide-receptor radiotherapy (PRRT).
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).
- A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound/negatively impact study objectives (documentation of the rationale must be provided)
- Prior external beam radiation dose to the kidneys of \>10 Gy (mean dose to functional renal volume).
- Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.