Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04090034
Eligibility Criteria:
Inclusion Criteria:
1. \> 18 years of age
2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:
* Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.
* Metastatic or Locally Advanced AND Inoperable
* Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)
* Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans with FDG for transformation to high-grade NET
* Well differentiated on path - Ki67 \< 20%
* Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs:
* Cr. \<1.7
* Hgb \>8
* WBC \>2K
* Plt \>75K
* Bili \< 3x normal limit
* No Octreotide within 30 days of administration.
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and sign the Informed Consent Form in English.
Exclusion Criteria:
* Do not meet the Study Inclusion Criteria laid out in section 6.3
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04090034
Study Brief:
Protocol Section:
NCT04090034