68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors

Neuroendocrine Tumors

Carcinoid Tumors

Neuroblastoma

Medulloblastoma

1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.

68Ga-DOTATOC PET/C

University of Iowa Health Care

Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors

Safety & Efficacy of 68Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging & Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT.

We will 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment after the initial PET/CT scan (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), we will measure response to treatment.

IPD are entered into the subject's electronic medical record and are shared with referring physicians when obtained.

Sue O'Dorisio

Professor of Medicine

The Octreoscan and 68Ga-DOTA-tyr3-Octreotide PET scans are read independently by two certified nuclear medicine physicians for discordant positive lesions.

1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y

1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y

3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y

Sarcoma, Synovial

Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y will be administered IV as a single injection on Day 0.

OTSA101-DTPA-90Y level 1

Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y will be administered IV as a single injection on Day 0.

OTSA101-DTPA-90Y level 2

Part 2 of the study 3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y will be administered IV as a single injection on Day 0.
This third dose level evaluation will be based on safety and preliminary efficacy data.

OTSA101-DTPA-90Y level 3

Centre Léon Bérard

First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10

First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10 (FZD10) in Patients With Relapsed or Refractory Non Resectable Synovial Sarcomas

Limiting Event is defined as unacceptable/unexpected biodistribution/binding of the mAb, and/or absence of tumor uptake. Data review will be performed on a patient per patient basis. The Biodistribution and binding of OTSA101-DTPA-111In will be analyzed. The rate of Limiting Event will be summarized by a proportion together with its 95% confidence interval.

The safety profile will be summarized with descriptive statistics including the following:
Occurrence of Severe Toxicities during the first 8 weeks post-injection of OTSA101-DTPA-90Y.
Occurrence of adverse events and serious adverse events during the study treatment period, including laboratory abnormalities, according to CTCAE v4.0 criteria.
Optimal recommended dose, defined as the dose level of OTSA101-DTPA-90Y with the best benefice-risk ratio taking into account the preliminary efficacy and safety data.

The following PK parameters will be collected: Cmax, tmax, t½: terminal half-life; AUC, Cl, Vss: Volume of distribution. These PK parameters will be calculated using non-compartmental analysis.

The safety profile of OTSA101-DTPA-111In will be summarized with descriptive statistics. The occurrence of adverse events and serious adverse events during the whole imaging part, including laboratory abnormalities, will be summarized by a proportion together with its 95% confidence interval.

The overall response rate is defined as the proportion of patients with a complete response or partial response on target lesions according to RECIST 1.1 criteria.

The clinical benefit rate is defined as the proportion of patients with a complete response or partial response or a stable disease on target lesions according to RECIST 1.1 criteria.

The duration of clinical response, measured from the time of first documented response until the first documented disease progression or death due to underlying cancer, will be described in responding subjects using descriptive statistics.

The following parameters will be collected: Cmax, tmax, t½: terminal half-life; AUC, Cl, Vss: Volume of distribution. Pharmacokinetics will be presented as descriptive statistics. Dose proportionality will be evaluated when applicable by an ANOVA mixed model. Accumulation will be assessed by Wilcoxon signed rank test.

yttrium/sarkom

Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors

First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10

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