Trial Outcomes & Findings for Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE (NCT NCT03673943)

Last Updated: 2022-12-22

Results Overview

The number of patients with NETs disease that was confirmed by SSTR(+) imaging using 64Cu-DOTATATE PET/CT and In111-Octreoscan (considered as the standard of truth imaging) A total of 63 subjects have been enrolled in the studies; among them 42 patients with known or suspected NET based on histology, or conventional imaging, or clinical evaluations and 21 healthy volunteers.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

63 participants

Primary outcome timeframe

12 months

Results posted on

2022-12-22

Participant Flow

Number of Subjects (planned and analyzed): 63 Analyzed: In total, 63 subjects (59 from the Phase 3 study and 4 from the Phase 1 study) were injected with study drug at an intended dose of 4.0 mCi and met the criteria to be analyzed for safety and efficacy.

Participant milestones

Participant milestones
Measure	PET/CT Imaging With 64Cu-DOTATATE 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET
Overall Study STARTED	63
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET/CT Imaging With 64Cu-DOTATATE n=63 Participants 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	54.37 years STANDARD_DEVIATION 15.65 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The number of patients with SSTR(+) NETs identified using 64Cu-DOTATATE PET-CT imaging as well as by the standard of truth methods. A total of 63 subjects have been enrolled in the studies, including 42 patients with known or suspected NET based on histology, conventional imaging, or clinical evaluations and 21 healthy volunteers.

Outcome measures

Outcome measures
Measure	PET/CT Imaging With 64Cu-DOTATATE n=62 Participants 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET
Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor true positive	30 Participants
Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor false negative	3 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The specificity of 64Cu-DOTATATE imaging has defined the ability of a radiotracer to correctly identify subjects who do not have a disease. It is defined by number of subjects who had no SSTR(+) NETs based on 64Cu-DOTATATE PET/CT imaging as well as SOT imaging using In111-Octreoscan.

The number of subjects who have no SSTR (+) NETs as determined by 64Cu-DOTATATE PET/CT as well using the standard of truth imaging (In111-Octrescan SPECT/CT).

Outcome measures

Outcome measures
Measure	PET/CT Imaging With 64Cu-DOTATATE n=62 Participants 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET
Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor true negative	28 Participants
Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor false positive	1 Participants

SECONDARY outcome

Timeframe: 12 months

Population: A number of subjects with localized SSTR(+) NETs or metastatic NETs detected by both Cu64-DOTATATE and SOT

The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT

Outcome measures

Outcome measures
Measure	PET/CT Imaging With 64Cu-DOTATATE n=30 Participants 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET
Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging localized NETs true positive	2 Participants
Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging localized NEts false negative	0 Participants
Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging metastatic NETs false positive	0 Participants
Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging metastatic NETs true negative	28 Participants

Adverse Events

PET/CT Imaging With 64Cu-DOTATATE

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PET/CT Imaging With 64Cu-DOTATATE n=63 participants at risk 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET
Gastrointestinal disorders nausea (grade 1)	1.6% 1/63 • Number of events 1 • Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration
General disorders headache (grade 1)	1.6% 1/63 • Number of events 1 • Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration
General disorders syncope (grade 2)	1.6% 1/63 • Number of events 1 • Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration
General disorders melanoderma (grade 1)	1.6% 1/63 • Number of events 1 • Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration
General disorders flushing (grade 1)	1.6% 1/63 • Number of events 1 • Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration
General disorders vomiting (both grade 1)	3.2% 2/63 • Number of events 2 • Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration

Additional Information

Ebrahim Delpassand

RadioMedix Inc

Phone: 7134999733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place