Trial Outcomes & Findings for Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan (NCT NCT03136328)

Results Overview

Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

During imaging process ( approximately 120 minutes)

Results posted on

2023-05-09

Participant Flow

Participants were recruited at Montefiore Medical Center which has medical specializing in the diagnosis and treatment of NETs. Eligible participants were those referred by their physicians for PET (Positron Emission Tomography) or CT imaging due to suspected or confirmed NETs.

Participant milestones

Participant milestones
Measure	68Ga-DOTATOC PET/CT Study participants will receive Gallium 68 (68Ga)-DOTATOC and undergo a PET/CT imaging study.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga-DOTATOC PET/CT n=11 Participants Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study to measure its ability to detect primary NET and any metastasis.
Age, Continuous	55.3 years STANDARD_DEVIATION 8.5 • n=11 Participants
Sex: Female, Male Female	9 Participants n=11 Participants
Sex: Female, Male Male	2 Participants n=11 Participants
Region of Enrollment United States	11 Participants n=11 Participants

PRIMARY outcome

Timeframe: During imaging process ( approximately 120 minutes)

Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.

Outcome measures

Outcome measures
Measure	68Ga-DOTATOC PET/CT n=11 Participants Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.	Conventional Imaging n=11 Participants All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or In-111 Octreoscan as standard care prior to 68Ga-DOTATOC imaging.
Sensitivity to Correctly Diagnose NET Lymph node metastasis	100 percent of NET correctly diagnosed	40 percent of NET correctly diagnosed
Sensitivity to Correctly Diagnose NET Bone metastasis	100 percent of NET correctly diagnosed	50 percent of NET correctly diagnosed
Sensitivity to Correctly Diagnose NET Primary lesions	75 percent of NET correctly diagnosed	75 percent of NET correctly diagnosed
Sensitivity to Correctly Diagnose NET Liver metastases	100 percent of NET correctly diagnosed	75 percent of NET correctly diagnosed

SECONDARY outcome

Timeframe: During imaging process ( approximately 120 minutes)

A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).

Outcome measures

Outcome measures
Measure	68Ga-DOTATOC PET/CT n=11 Participants Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.	Conventional Imaging All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) or In-111 Octreoscan as standard care prior to 68Ga-DOTATOC imaging.
Specificity to Detect True Negative Primary lesions	100 percent of tumors identified as non-NET	—
Specificity to Detect True Negative Liver metastases	100 percent of tumors identified as non-NET	—

Adverse Events

68Ga-DOTATOC PET/CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charito Love, MD

Montefiore Medical Center

Phone: 718-406-8462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place