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New treatment option for Digestive System Neuroendocrine Tumor
Official title Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors.
ClinicalTrials.gov ID: NCT07150546
What this study is testing
What is Lutetium Lu 177 Dotatate?
Lutetium Lu 177 Dotatate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for digestive system neuroendocrine tumor.
Also referred to as 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, 437608-50-9, Lutathera, Lutetium (177Lu) Oxodotreotide, 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera, Lutetium (177Lu) Oxodotreotide, Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate, Lutetium Lu 177 Dotatate.
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
- This phase I trial tests the safety and effectiveness of stereotactic body radiation therapy (SBRT) followed by 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in treating patients with large well-differentiated grade 1-2 digestive system neuroendocrine tumors that cannot be removed by surgery (unresectable). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body.
- Phase 1: an early, usually small safety study
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
- Male or female
- Age ≥ 18 years
- Patient must be able to provide study specific informed consent
- Pathologically confirmed neuroendocrine tumor fulfilling all of the following criteria
- Well-differentiated, grade 1-2
You likely can't join if
- Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site/region
- Contraindications to radiation therapy including inflammatory bowel disease, systemic sclerosis, etc.
- Brain metastases or any metastases extending into the spinal canal
- Unable to obtain confirmation of payment coverage for any planned radiation treatment
See the full eligibility criteria
- Male or female
- Age ≥ 18 years
- Patient must be able to provide study specific informed consent
- Pathologically confirmed neuroendocrine tumor fulfilling all of the following criteria
- Well-differentiated, grade 1-2
- Unresectable (prior resection is allowable), verified by tumor board or surgical oncology (surg onc)
- Progression after one or two prior lines of systemic therapy
- Somatostatin-receptor positive disease as determined by positive radiotracer-labeled DOTATATE PET/CT scan (modified Krenning score 3+)
- One or more large lesions measuring 3 or more cm on contrast-enhanced CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Estimated glomerular filtration rate (GFR) \> 30 mL/min (within 90 days prior to study registration)
- Total bilirubin ≤ 3 x upper limit of normal (within 90 days prior to study registration)
- Albumin \> 30 g/L (within 90 days prior to study registration)
- White blood cell (WBC) ≥ 2,000 cells/mm\^3 (within 90 days prior to study registration)
- Platelets ≥ 70000 cells/mm\^3 (within 90 days prior to study registration)
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable.) (within 90 days prior to study registration)
- Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site/region
- Contraindications to radiation therapy including inflammatory bowel disease, systemic sclerosis, etc.
- Brain metastases or any metastases extending into the spinal canal
- Unable to obtain confirmation of payment coverage for any planned radiation treatment
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, 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 Atlanta, Georgia, 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.